Lt
by Linfen Houma Economic Development Zone Yongxing Medical Device Co., Ltd EUDAMED
Active
Ref Silicone gingivaModel Hand adjusted weight body, Light body, Superfluid, Soft lining, Gun mixed weight body, Jaw record, Silicone gingiva
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697671479SRCM01ZP | Date13 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Silicone rubber copy material
- Model / Reference
- Hand adjusted weight body, Light body, Superfluid, Soft lining, Gun mixed weight body, Jaw record, Silicone gingiva
- Primary DI / UDI-DI
- 06976714790367
- Basic UDI-DI
- 697671479SRCM01ZP
- EMDN Code
- M04040702 Silicone dressings, combined with other substances
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000037038
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Linfen Houma Economic Development Zone Yongxing Medical Device Co., Ltd
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Properties
Other properties (13)
- Sterile: No
- 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