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Lactate dehydrogenase (LDH)-Liquizyme (4+1)
EUDAMEDClass B (EU MDR)
Ref 283 001Ref 283 005Ref 283 003Ref 283 002
Identity
- Trade Name
- Lactate dehydrogenase (LDH)-Liquizyme (4+1) EUDAMED
- Device Name
- Lactate dehydrogenase (LDH)-Liquizyme (4+1) EUDAMED
- Model / Reference
- 283 001 EUDAMED283 005 EUDAMED283 003 EUDAMED283 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G458283001A2 EUDAMEDG458283005AA EUDAMEDG458283003A6 EUDAMEDG458283002A4 EUDAMED
- Basic UDI-DI
- ++G458283N8 EUDAMED
- EMDN Code
- W01010120 LACTATE DEHYDROGENASE P ( LDH - P --> L ) 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
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
New Device
No
EUDAMED
Lactate dehydrogenase (LDH)-Liquizyme (4+1) by Spectrum for Diagnostic Industries (Joint Stock Company) — Class B — IVDR — listed in EUDAMED
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 | ++G458283N8 | Class B | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (8)
- EUDAMED 2f9ab52a-2028-43d1-835c-6094b1a87139 61 fields · synced Oct 6, 2026
- EUDAMED 95c840e9-896d-4af3-ba7b-8a4e8c4d181a 61 fields · synced May 17, 2026
- EUDAMED ffae55fd-e217-48fc-8ea9-02609c4825a4 61 fields · synced May 17, 2026
- EUDAMED ebe717ea-62a1-452d-b9c1-2aac61ec5f73 61 fields · synced May 18, 2026
- EUDAMED bc892bea-8aef-4c6a-8c9c-f17c2262268b 61 fields · synced Jul 9, 2026
- EUDAMED 4d2dbf6b-4bc5-48a3-93fe-1e61fd66eb54 61 fields · synced Jul 23, 2026
- EUDAMED 9b1cbc75-55fc-4452-9d6f-04087629b543 61 fields · synced Jul 24, 2026
- EUDAMED d64e11d2-88ea-42c8-9a44-0bc0eaa8748a 61 fields · synced Sep 17, 2026