Identity
- Trade Name
- Van Gogh FDA UDI
- Generic Name
- Tissue specimen digital imaging scanner IVD FDA UDI
- Device Name
- Patient Biopsy Kit EUDAMED
- Model / Reference
- PBK-05 EUDAMEDSample Holder Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860012995318 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600129953PBK-05RR EUDAMED
- Direct Marketing DI
- 00860012995318 EUDAMED
- FDA Product Code
- IBM FDA UDI
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Tissue specimen digital imaging scanner IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3600 FDA UDI
- Market of Registration
- Italy 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Patient Biopsy Kit by CellTivity Scientific, 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 | 08600129953PBK-05RR | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- CellTivity Scientific, Inc.
- EUDAMED SRN
- US-MF-000050094
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 1ab22bb9-fde4-42dc-9a00-9b28bfde7844 61 fields · synced Jul 24, 2026
- FDA UDI 0a082b8c-8cfb-4a2b-b63a-56dcdd569fe1 32 fields · synced May 30, 2026