Identity
- Trade Name
- ADAM-rWBC HT EUDAMEDFDA UDI
- Generic Name
- White blood cell count IVD, kit, cell count FDA UDI
- Device Name
- ADAM-rWBC HT EUDAMEDThe ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products. FDA UDI
- Model / Reference
- ADAM-rWBC HT EUDAMEDFDA UDI
- Description
- The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products. FDA UDI
Identifiers
- Catalog Number
- ADAM-rWBC HT FDA UDI
- Primary DI / UDI-DI
- 08809317540993 EUDAMEDFDA UDI
- Basic UDI-DI
- 880931754rWBCHT74 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
- 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
No
FDA UDI
ADAM-rWBC HT 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 | 880931754rWBCHT74 | 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 9435c597-05b4-4561-a2c2-f1dbb9574c6a 61 fields · synced Jul 12, 2026
- FDA UDI f06b1a17-e09d-41f3-b4dc-80bfa1fce13f 35 fields · synced May 29, 2026