Identity
- Device Name
- Immunochromogenic Reagent EUDAMED
- Model / Reference
- 30ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937455441482 EUDAMED
- Basic UDI-DI
- B-06937455441482 EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Immunochromogenic Reagent by Xiamen Talent Biomedical Technology Co., Ltd — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06937455441482 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06937455441482 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Talent Biomedical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000039397
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f975240e-9216-4802-97e3-861b65e91479 61 fields · synced Oct 6, 2026