Identity
- Trade Name
- Lactate – Liquizyme EUDAMED
- Device Name
- Lactate – Liquizyme EUDAMED
- Model / Reference
- 274 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G4582740019W EUDAMED
- Basic UDI-DI
- ++G458274N7 EUDAMED
- EMDN Code
- W01010218 LACTATE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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
New Device
No
EUDAMED
Lactate – Liquizyme by Spectrum for Diagnostic Industries (Joint Stock Company) — Class B — 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 | ++G458274N7 | Class B | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 99519607-7722-4711-ba56-bd32e88dfa3b 61 fields · synced Oct 6, 2026
- EUDAMED 13d59d69-5ace-4d35-96f1-94edf04636d1 61 fields · synced Aug 3, 2026