Lt
by Linfen Houma Economic Development Zone Yongxing Medical Device Co., Ltd 3 variants
Ref Hand adjusted weight body, Light body, Superfluid, Soft lining, Gun mixed weight body, Jaw recordModel Hand adjusted weight body, Light body, Superfluid, Soft lining, Gun mixed weight body, Jaw record, Silicone gingiva
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697671479SRCM01ZP | Date13 Dec 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
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
- 06976714790305, 06976714790312, 06976714790329, 06976714790336, 06976714790343, 06976714790350
- Basic UDI-DI
- 697671479SRCM01ZP
- EMDN Code
- M04040702 Silicone dressings, combined with other substances
- Device Class
- Class I
- EU 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