Identity
- Trade Name
- Ammonia – single reagent EUDAMED
- Device Name
- Ammonia – single reagent EUDAMED
- Model / Reference
- 220 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041004440 EUDAMED
- Basic UDI-DI
- B-62230041004440 EUDAMED
- EMDN Code
- W01010301 AMMONIA EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Ammonia – single reagent by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDD — listed in EUDAMED
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-62230041004440 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 6a146c84-9b7f-432f-8b7d-88aeea31beff 61 fields · synced Jul 9, 2026