Identity
- Trade Name
- ADAM-rWBC2 EUDAMEDFDA UDI
- Generic Name
- White blood cell count IVD, kit, cell count FDA UDI
- Device Name
- ADAM-rWBC EUDAMEDADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit. FDA UDI
- Model / Reference
- ADAM-rWBC EUDAMEDADAM-rWBC2 EUDAMEDFDA UDI
- Description
- ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit. FDA UDI
Identifiers
- Catalog Number
- ADAM-rWBC2 FDA UDI
- Primary DI / UDI-DI
- 08809317540498 EUDAMEDFDA UDI
- Basic UDI-DI
- 880931754ADAMJC EUDAMED
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
- GMDN Term
- White blood cell count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Greece 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
No
FDA UDI
ADAM-rWBC2 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 | 880931754ADAMJC | 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 fb2b3d9d-9543-449d-91a1-714d07c07115 61 fields · synced Jul 14, 2026
- FDA UDI 53b7eda2-fd13-4646-a5f2-fec93650fd89 35 fields · synced May 30, 2026