Apothi-Tech
by Jiangsu NewValue Medical Products Co., Ltd. China EUDAMED
Ref LE1699Model Silicone-Border
EMDN M04010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697020682FDSBSF7 | Date5 Nov 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Foam Dressing
- Model / Reference
- Silicone-Border, LE1699
- Primary DI / UDI-DI
- 03664788007179
- Basic UDI-DI
- 697020682FDSBSF7
- Unit of Use DI
- 23664788007173
- EMDN Code
- M04010102 Polyurethane (or other material) adhesive dressings, with absorbent pad
- Device Class
- Class IIb
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000008202
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Jiangsu Newvalue Medical Products Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED f497ebac-d820-410f-a446-df77a3e4cd5e