← Back to catalogue
Amanilab auto P&D System
EUDAMEDClass A (EU MDR)
Ref P205410101Model Amanilab EP201、Amanilab EP202、Amanilab EP101、Amanilab EP102
Identity
- Trade Name
- Amanilab auto P&D System EUDAMED
- Device Name
- Amanilab auto P&D System EUDAMED
- Model / Reference
- Amanilab EP201、Amanilab EP202、Amanilab EP101、Amanilab EP102 EUDAMEDP205410101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974345075419 EUDAMED
- Basic UDI-DI
- 697434507P20PQ EUDAMED
- Direct Marketing DI
- 06974345075419 EUDAMED
- EMDN Code
- W02060101 AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Amanilab auto P&D System by Amazing Biotech (Shanghai) 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 | 697434507P20PQ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amazing Biotech (Shanghai) Co., LTD
- EUDAMED SRN
- CN-MF-000022383
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED a056627f-1e06-40e1-aa4d-5afeb384a778 61 fields · synced Jul 12, 2026