Identity
- Trade Name
- C-Chip EUDAMEDFDA UDI
- Generic Name
- Full blood count IVD, kit, cell count FDA UDI
- Device Name
- The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-M01 grid pattern is exactly same as the Malassez. It consists of 25 large squares, each measuring 0.2 x 0.25 mm and the depth of the chamber is 0.2 mm. Each square has a total volume of 0.01 mm3 or 10-5 cm3. The large squares are subdivided into 20 small squares with an area of 0.0025 mm2. Cells per mL = average count per large square x dilution factor x 105 (dilution factor) FDA UDI
- Model / Reference
- C-Chip EUDAMEDDHC-M01 EUDAMEDFDA UDI
- Description
- The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-M01 grid pattern is exactly same as the Malassez. It consists of 25 large squares, each measuring 0.2 x 0.25 mm and the depth of the chamber is 0.2 mm. Each square has a total volume of 0.01 mm3 or 10-5 cm3. The large squares are subdivided into 20 small squares with an area of 0.0025 mm2. Cells per mL = average count per large square x dilution factor x 105 (dilution factor) FDA UDI
Identifiers
- Catalog Number
- DHC-M01 FDA UDI
- Primary DI / UDI-DI
- 08809317540603 EUDAMEDFDA UDI
- Basic UDI-DI
- 880931754C-ChipH5 EUDAMED
- FDA Product Code
- GHO FDA UDI
- EMDN Code
- W050301029099 SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER EUDAMED
- GMDN Term
- Full blood count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.6160 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
C-Chip 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 | 880931754C-ChipH5 | 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 1a989427-9596-463a-866c-a93130c973bc 61 fields · synced Jun 19, 2026
- FDA UDI 495d40e4-a81b-42ff-b74d-d18ffd00907d 34 fields · synced May 30, 2026