Identity
- Trade Name
- PocketChem BA (PA-4140) EUDAMED
- Device Name
- PocketChem BA (PA-4140) EUDAMED
- Model / Reference
- 20503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-20503F3 EUDAMED
- Basic UDI-DI
- B-20503F3 EUDAMED
- EMDN Code
- W0201010203 BLOOD-AMMONIA CHECKERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland 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
PocketChem BA (PA-4140) by ARKRAY Factory, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-20503F3 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (1)
- EUDAMED 2da1e1f0-49b4-4bdc-b1c4-8f804f40fa44 61 fields · synced Jun 19, 2026