Identity
- Trade Name
- Promotor Sample Collection Kit EUDAMED
- Device Name
- Sample Collection Kit EUDAMED
- Model / Reference
- P121-1471-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921756496593 EUDAMED
- Basic UDI-DI
- 6921756499990022WX EUDAMED
- EMDN Code
- W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Promotor Sample Collection Kit by Acon Biotech (Hangzhou) Co., Ltd. — 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 | 6921756499990022WX | Class A | Active |
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Manufacturer
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000006977
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 6c948c8b-14b7-4447-a2cc-7b8cd672331c 61 fields · synced Jul 18, 2026