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Ki-67 Antibody Reagent
EUDAMEDClass IVD General (EU MDR)
Ref 4910103Ref 4910102
Identity
- Trade Name
- Ki-67 Antibody Reagent EUDAMED
- Device Name
- Ki-67 Antibody Reagent EUDAMED
- Model / Reference
- 4910103 EUDAMED4910102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977644783948 EUDAMED06977644783931 EUDAMED
- Basic UDI-DI
- B-06977644783948 EUDAMEDB-06977644783931 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
Ki-67 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-06977644783948 | Class IVD General | 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 (2)
- EUDAMED a9d90793-0332-43e0-a80b-a1bc8775b9b5 61 fields · synced Jul 29, 2026
- EUDAMED 2eeef463-4bdc-45c6-b133-5b465ebbdddf 61 fields · synced May 17, 2026