Identity
- Trade Name
- ADAMII EUDAMEDFDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- ADAMII EUDAMEDADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients. FDA UDI
- Model / Reference
- ADAMII EUDAMEDFDA UDI
- Description
- ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809317540627 EUDAMEDFDA UDI
- Basic UDI-DI
- 880931754ADAMIIFC EUDAMED
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
- GMDN Term
- Haematological cell analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Adamii by NanoEnTek, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 880931754ADAMIIFC | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 7b9bb2bd-71d1-41cd-a25a-cda7ba742a3b 61 fields · synced Jul 24, 2026
- FDA UDI 0a0a438f-54dc-48b5-8a8f-6d32fccd7665 34 fields · synced May 30, 2026