Identity
- Trade Name
- Mini Dock EUDAMED
- Device Name
- Integrated Nucleic Acid Testing Device EUDAMED
- Model / Reference
- PM001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975327120066 EUDAMED
- Basic UDI-DI
- 697532712PM001FP EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Mini Dock by Guangzhou Pluslife Biotech 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 | 697532712PM001FP | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Pluslife Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000025784
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5775e4bf-1143-41ed-afc1-f8487783738f 61 fields · synced Jun 17, 2026