← Back to catalogue
ADAMII™-CD3/CD4/CD8 Kit
EUDAMEDClass IVD General (EU MDR)
Ref CD348K-025Model ADAMII™-CD3/CD4/CD8 Kit
Identity
- Trade Name
- ADAMII™-CD3/CD4/CD8 Kit EUDAMED
- Device Name
- ADAMII™-CD3/CD4/CD8 Kit EUDAMED
- Model / Reference
- ADAMII™-CD3/CD4/CD8 Kit EUDAMEDCD348K-025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317541020 EUDAMED
- Basic UDI-DI
- B-08809317541020 EUDAMED
- EMDN Code
- W0103010199 REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Croatia EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
ADAMII™-CD3/CD4/CD8 Kit by NanoEnTek, Inc. — 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-08809317541020 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED f18c9f9e-8e98-4154-905d-7af46ecb8794 61 fields · synced Jul 29, 2026
- EUDAMED 290c6940-5db8-4a7c-93e1-67071056ebfc 61 fields · synced Jul 29, 2026