Quality and compliance
KombiMED GmbH supplies only CE-marked devices under EU MDR 2017/745 or, for in-vitro diagnostics, IVDR 2017/746. Before a device ships, KombiMED checks that its documentation is complete and current; storage and transport follow GDP, including a cold chain down to −86 °C; and registration in the target market, installation, training and warranty service follow under the same contract. KombiMED's quality management is aligned with ISO 9001 — it does not claim a certification it does not hold.
Who holds which certificate?
Conformity of a device is the manufacturer's responsibility; checking it, moving it and keeping it registered is KombiMED's. The table shows who holds each certificate or approval and what KombiMED does with it.
| Certificate or rule | Held by | What KombiMED does |
|---|---|---|
| CE marking under EU MDR 2017/745 or IVDR 2017/746 | Manufacturer | Supplies only CE-marked devices and checks before shipment that the documentation is complete and current. |
| ISO 13485 quality management system | Manufacturer | Keeps the ISO 13485 evidence with the device documentation for registration. |
| ISO 9001 quality management | KombiMED (aligned, not certified) | Runs its own quality management aligned with ISO 9001. |
| Good Distribution Practice (GDP) | KombiMED | Imports, stores and transports under GDP, including a cold chain down to −86 °C. |
| Export control and customs | KombiMED | Checks exports against the German Foreign Trade Act (AWG) and the EU dual-use regulation and clears them under the Union Customs Code. |
| EAEU and national registration | Registration in the target market | Prepares the dossier, submits it and keeps the registration valid. |
| CAP PT/EQA programmes | College of American Pathologists | Official distributor of CAP PT/EQA programs for most countries in Central Asia and the Caucasus region. |
What is checked before a device ships?
Before a device ships, KombiMED checks these points:
- CE marking and the declaration of conformity are present and current;
- the technical documentation needed for registration in the target market is complete;
- the export is checked against the German Foreign Trade Act and the EU dual-use regulation;
- temperature-sensitive goods travel in the cold chain, down to −86 °C;
- fragile instruments such as analysers and autoclaves are packed and handled for transport;
- customs clearance is prepared under the Union Customs Code.
How is a device registered outside the EU?
A CE mark does not open the Eurasian Economic Union. Each target market has its own registration, and without it a device cannot be sold, installed or serviced there. KombiMED takes over this part in three steps.
Dossier
The registration dossier is prepared from the manufacturer's technical documentation and adapted to the target market.
Submission
The dossier goes to the authority — EAEU registration and country-specific certification, including metrological approval where required.
Lifecycle
Registrations stay valid as devices, software versions and regulations change.
How is equipment delivered?
KombiMED ships from its head office and warehouse in Dortmund, Germany: standard delivery takes 2–4 weeks, with customs clearance, insurance and CIP delivery door-to-door, and temperature-sensitive goods travel in the cold chain down to −86 °C.
Dortmund head office and warehouse
Head office and warehouse in Dortmund, Germany; spare parts and consumables ship from there.
2–4 weeks standard delivery
Standard delivery from the German warehouse takes 2–4 weeks, including customs.
Door-to-door, insured
Customs clearance, insurance and CIP delivery door-to-door.
Cold chain down to −86 °C
Temperature-sensitive goods travel under GDP in the cold chain.
Consolidated shipments
Freight consolidation and a full set of accompanying documents for every delivery from Europe.
12,500+ deliveries to 35+ countries
Experience with customs procedures, certification and registration across Central Asia, the Caucasus and Eastern Europe.
What does the warranty cover?
New equipment comes with the manufacturer's warranty, and KombiMED handles it under the same contract — one procurement partner, a unified warranty and a single invoice, with warranty service from 5 service centers across Central Asia and the Caucasus. Extended service contracts, staff training and technical support are available on top.
What happens after installation?
After installation, KombiMED stays responsible for the device: staff training on site, warranty service and support from 5 service centers across Central Asia and the Caucasus with a 24-hour response time. If a safety issue arises, KombiMED reports device-related incidents under MDR 2017/745 and IVDR 2017/746, manages field safety corrective actions together with the manufacturer and cooperates with the competent authorities — in Germany, the BfArM.
Is pre-owned equipment checked too?
Yes. Pre-owned and refurbished equipment comes in 4 quality levels — from the economical as-is option without warranty to premium refurbishment with a one-year warranty — so the level of confidence matches the budget.
| Quality level | Warranty | What is done |
|---|---|---|
| As-is | No warranty | Equipment in its current condition — for teaching laboratories, research institutions or as a source of spare parts. |
| Basic refurbishment | 3 months | Basic inspection and refurbishment, replacement of critically worn components and basic calibration. |
| Standard refurbishment | 6 months | Full refurbishment cycle: diagnostics, replacement of worn parts, calibration, software update, final testing. |
| Premium refurbishment | 12 months | Brought to a condition close to new: all wear assemblies replaced, current software version, extended warranty. |
Certified pre-owned equipment →
Where does CAP fit in?
For medical laboratories, quality does not end with the instrument. KombiMED is the official distributor of CAP PT/EQA programs for most countries in Central Asia and the Caucasus region and supports laboratories on the way to CAP accreditation and ISO 15189.
- CAP accreditation readiness check
- CAP accreditation explained
- Accreditation – CAP LAP and ISO norms
- Quality control services
How do I get the documents for my device?
Write to sales@kombi-med.com or use the contact form, name the device or attach your tender list, and ask for its declaration of conformity, certificates and registration status in your country.
Need the documents for a specific device?
Name the device or attach your tender list and ask for its declaration of conformity, certificates and registration status in your country.
Sources
Last reviewed · KombiMED GmbH, Dortmund
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