Identity
- Device Name
- HLA-B27 Kit EUDAMED
- Model / Reference
- 50T EUDAMED8920197CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974501891051 EUDAMED
- Basic UDI-DI
- 69745018900B002502VY EUDAMED
- EMDN Code
- W0103080106 ANTIBODIES FOR LYMPHOCYTE SUBTYPING EUDAMED
Classification
- Device Class
- Class B 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
HLA-B27 Kit by Agilent Biosciences (Hangzhou) Co., Ltd. — 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 | 69745018900B002502VY | Class B | Active |
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Manufacturer
- Manufacturer
- Agilent Biosciences (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013066
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED 6836ef82-55c5-40bd-9708-9fbded68228b 61 fields · synced Jun 18, 2026