Identity
- Trade Name
- CTCD FDA UDI
- Generic Name
- Circulating tumour cell separation system cassette IVD FDA UDI
- Device Name
- CTCD EUDAMED
- Model / Reference
- CTD-C103 EUDAMEDCTUD-C103 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800204900029 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800204900029WG EUDAMED
- FDA Product Code
- GKH FDA UDI
- EMDN Code
- W0503010280 SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Circulating tumour cell separation system cassette IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.5240 FDA UDI
- Market of Registration
- Germany 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ctcd by CTCELLS, 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 | 8800204900029WG | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- CTCELLS Inc.
- EUDAMED SRN
- KR-MF-000049564
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED b6e80bd2-6ba1-4a76-a622-6ccfea0506b8 61 fields · synced Jun 19, 2026
- FDA UDI cb961119-3e19-40d4-8acb-0bac2f727a0b 32 fields · synced May 30, 2026