← Back to catalogue
SPOTCHEM Electrolyte Control [Na, K, Cl]
EUDAMEDClass IVD General (EU MDR)
Ref 77967
Identity
- Trade Name
- SPOTCHEM Electrolyte Control [Na, K, Cl] EUDAMED
- Device Name
- SPOTCHEM Electrolyte Control [Na, K, Cl] EUDAMED
- Model / Reference
- 77967 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-77967KR EUDAMED
- Basic UDI-DI
- B-77967KR EUDAMED
- EMDN Code
- W0101050204 ELECTROLYTE CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SPOTCHEM Electrolyte Control [Na, K, Cl] 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-77967KR | Class IVD General | 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 (1)
- EUDAMED 4a846e0b-7254-4920-8bfb-0c1f16ab4791 61 fields · synced Jul 21, 2026