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A1c/Ce Low Volume Sample Collection Tube
EUDAMEDClass A (EU MDR)
Ref 9216
by sebia
Identity
- Trade Name
- A1C/CE LOW VOLUME SAMPLE COLLECTION TUBE EUDAMED
- Device Name
- A1C/CE LOW VOLUME SAMPLE COLLECTION TUBE EUDAMED
- Model / Reference
- 9216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607360092163 EUDAMED
- Basic UDI-DI
- 3607369216BUEY EUDAMED
- EMDN Code
- W050301020280 SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
A1c/Ce Low Volume Sample Collection Tube by Sebia — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3607369216BUEY | Class A | Active |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (1)
- EUDAMED c4448a98-482a-466b-8fb1-f6553e7f00bf 61 fields · synced Jun 18, 2026