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Brucella A/M
EUDAMEDClass IVD General (EU MDR)
Ref 710 004Ref 710 003Ref 710 001
Identity
- Trade Name
- Brucella A/M EUDAMED
- Device Name
- Brucella A/M EUDAMED
- Model / Reference
- 710 004 EUDAMED710 003 EUDAMED710 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041011998 EUDAMED62230041011820 EUDAMED62230041011684 EUDAMED
- Basic UDI-DI
- B-62230041011998 EUDAMEDB-62230041011820 EUDAMEDB-62230041011684 EUDAMED
- EMDN Code
- W0105011701 BRUCELLA 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
Brucella A/M by Egyptian Company For Biotechnology-Spectrum Diagnostics — 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-62230041011998 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED caf3aa40-5001-4e9f-9967-3dce9c45c9bd 61 fields · synced Oct 6, 2026
- EUDAMED 055c1843-891f-433f-ba07-3d35d695627a 61 fields · synced May 17, 2026
- EUDAMED 4be8df01-ecdd-4318-a9aa-ab830d6bf71a 61 fields · synced May 18, 2026