← Back to catalogue
PocketChem UA (PU-4010)
EUDAMEDClass A (EU MDR)
Ref 107334Ref 102678Ref 20705Ref 102677Ref 20704Ref 20707Ref 107333
Identity
- Trade Name
- PocketChem UA (PU-4010) EUDAMED
- Device Name
- PocketChem UA (PU-4010) EUDAMED
- Model / Reference
- 107334 EUDAMED102678 EUDAMED20705 EUDAMED102677 EUDAMED20704 EUDAMED20707 EUDAMED107333 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486033394 EUDAMEDD-102678MM EUDAMEDD-20705FH EUDAMEDD-102677MK EUDAMEDD-20704FF EUDAMEDD-20707FM EUDAMED04987486033387 EUDAMED
- Basic UDI-DI
- 4987486BC0107332GK EUDAMEDB-102678MM EUDAMEDB-20705FH EUDAMEDB-102677MK EUDAMEDB-20704FF EUDAMEDB-20707FM EUDAMED
- EMDN Code
- W020101020102 SEMI-AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Ireland EUDAMEDRomania EUDAMEDItaly 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
PocketChem UA (PU-4010) by ARKRAY Factory, Inc. — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 4987486BC0107332GK | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 4987486BC0107332GK | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (7)
- EUDAMED fe2bc5ea-9895-4bdb-bec7-680a24469c74 61 fields · synced Jul 30, 2026
- EUDAMED 044f4b88-5182-47d0-8f8c-d869e2dd7ca4 61 fields · synced May 16, 2026
- EUDAMED d61f971a-b993-40aa-9e05-f48c28b2d917 61 fields · synced May 16, 2026
- EUDAMED 31e713bd-fbe3-4cb3-b9af-75f28dd56505 61 fields · synced May 17, 2026
- EUDAMED 07e3c83b-2043-4f19-86de-34fe214023f5 61 fields · synced May 17, 2026
- EUDAMED 06189342-f650-4a36-9988-25fcda875a6e 61 fields · synced May 18, 2026
- EUDAMED ff16d3f4-32c0-4e7c-a87a-4e402b092ffa 61 fields · synced May 19, 2026