Kessler-Aquafix
by Ningbo Chinmed Technology Co., Ltd 5 variants
Ref KD.A27, KD.A16, KD.A10, KD.A15, KD.A17, KD.A13, KD.A14, KD.A24, KD.A21Model FL-TM, FT-TM & FT-FW & FT-XS
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697286436sdt7H | Date28 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- PU Island DressingWound Dressings
- Model / Reference
- FL-TM, KD.A27, KD.A16, KD.A10, KD.A15, KD.A17, KD.A13, FT-TM & FT-FW & FT-XS, KD.A14, KD.A24, KD.A21
- Primary DI / UDI-DI
- 06972864362744, 06972864362386, 06972864362140, 06972864362157, 06972864362737, 06972864362362, 06972864362379, 06972864362164, 06972864362355
- Basic UDI-DI
- 697286436sdt7H, 697286436200004X
- EMDN Code
- M04010102 Polyurethane (or other material) adhesive dressings, with absorbent pad
- Device Class
- Class IIa
- EU market of registration
- GreeceCyprus
Manufacturer details
- EUDAMED SRN
- CN-MF-000023983
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Ningbo Chinmed Technology Co., Ltd.
Properties
Other properties (12)
- 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