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Fully-auto Specific Protein Analyzer
EUDAMEDClass A (EU MDR)
Ref PA120Ref PA240Model PA480，PA240
Identity
- Trade Name
- Fully-auto Specific Protein Analyzer EUDAMED
- Device Name
- Fully-auto Specific Protein Analyzer EUDAMED
- Model / Reference
- PA120 EUDAMEDPA480，PA240 EUDAMEDPA240 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334800965 EUDAMED06950334819479 EUDAMED
- Basic UDI-DI
- 69503348PAA002F9 EUDAMED69503348PAA005FF EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMEDW0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece EUDAMEDTürkiye 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
Fully-auto Specific Protein Analyzer by Genrui Biotech Inc. — 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 | 69503348PAA002F9 | Class A | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 5671511e-03e0-4e75-a094-1dc969f28a82 61 fields · synced Jul 29, 2026
- EUDAMED 4bd89ddc-e5c8-4251-bc53-ec69c2df8f25 61 fields · synced May 17, 2026