Portal Entry Kit with FlowPort Touch, CL/SZ
by T.A.G. Medical products corporation LTD. EUDAMEDGUDID
Active
Ref CAT00245Model FlowPort Touch
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number81012846FlowPortTouchYU | Date29 Jun 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10810128460863 | Date18 Jun 2025 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Generic Name
- Arthroscopic surgical procedure kit, non-medicated, single-use
- Device Name
- FlowPort Touch
- Model / Ref / Catalog
- FlowPort Touch, CAT00245, 625200st
- Primary DI / UDI-DI
- 10810128460863
- Basic UDI-DI
- 81012846FlowPortTouchYU
- FDA Product Code
- LXH, KDD
- EMDN Code
- K030203, K030212
- GMDN Term
- Arthroscopic surgical procedure kit, non-medicated, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 888.4540, 878.4800
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IL-MF-000029151
- Authorised representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Other devices from T.A.G. Medical products corporation LTD.
See all devices from T.A.G. Medical products corporation LTD. →
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No