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Adam2 & Cd34k-025
EUDAMEDClass IVD General (EU MDR)
Ref ADAM2 & CD34K-025Model ADAMII & ADAMII™ CD34 Kit
Identity
- Model / Reference
- ADAMII & ADAMII™ CD34 Kit EUDAMEDADAM2 & CD34K-025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317540610 EUDAMED
- Basic UDI-DI
- B-08809317540610 EUDAMED
- EMDN Code
- W0103010199,W0202010101 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
Yes
EUDAMED
Adam2 & Cd34k-025 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-08809317540610 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 2e29f561-ff0d-48e0-a251-a02a1b67313f 61 fields · synced Jul 8, 2026
- EUDAMED 440d92d9-f640-4d02-8e02-84e477fdad28 61 fields · synced Jul 8, 2026