Identity
- Trade Name
- Immunochromogenic Reagent EUDAMED
- Device Name
- Immunochromogenic Reagent EUDAMED
- Model / Reference
- HI EUDAMED4980722 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977644783436 EUDAMED
- Basic UDI-DI
- 6977644784980729S EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Immunochromogenic Reagent by Shenzhen Dakewe Bio-Engineering Co., Ltd. — Class A — IVDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6977644784980729S | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000002174
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 353f4550-5718-42f0-bc1a-6cb6e0539e08 61 fields · synced Jun 19, 2026