Identity
- Trade Name
- Optic Cuvette EUDAMED
- Device Name
- Optical cuvette EUDAMED
- Model / Reference
- 1000PCS/Box EUDAMED20.99.0053A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117454309 EUDAMED
- Basic UDI-DI
- 6970493090803003PF EUDAMED
- Direct Marketing DI
- 06976117454309 EUDAMED
- EMDN Code
- W0202020185 COAGULOMETERS - CONSUMABLES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Optic Cuvette by Shenzhen Dymind Biotechnology 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 | 6970493090803003PF | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 8809e02c-7c87-4cae-92c6-58e7f8b5bac3 61 fields · synced Jul 27, 2026