Identity
- Trade Name
- CK20 Antibody Reagent EUDAMED
- Device Name
- CK20 Antibody Reagent EUDAMED
- Model / Reference
- 4910372 EUDAMED4910373 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973471960835 EUDAMED06977644787540 EUDAMED
- Basic UDI-DI
- B-06973471960835 EUDAMEDB-06977644787540 EUDAMED
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
CK20 Antibody Reagent by Shenzhen Dakewe Bio-Engineering Co., Ltd. — 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-06973471960835 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000002174
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 2c85e380-46a5-42bb-8f19-00b25bb5d6ab 61 fields · synced Aug 2, 2026
- EUDAMED 1e5f1b59-8c73-4c01-b54f-e0ed4636e80d 61 fields · synced May 19, 2026