Identity
- Trade Name
- MLB 2 EUDAMED
- Device Name
- MLB 2 EUDAMED
- Model / Reference
- 805200 EUDAMED805205 EUDAMED12014332 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611969950881 EUDAMED07611969950904 EUDAMED03610522203338 EUDAMED
- Basic UDI-DI
- 361052A002928C EUDAMED
- EMDN Code
- W0103030306 ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Mlb 2 by Bio-Rad Medical Diagnostics Gmbh — Class A — 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 | 361052A002928C | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
- EUDAMED SRN
- DE-MF-000019864
Sources (3)
- EUDAMED bc6f67dd-e626-4981-9062-8eea14af86d4 61 fields · synced Jul 22, 2026
- EUDAMED 870985b8-3a9e-41eb-a98e-4d1d8e6dd3fc 61 fields · synced May 17, 2026
- EUDAMED bb98ec76-4338-49ce-8fd9-0c2301216696 61 fields · synced May 17, 2026