Splint
by Anping Guardian Medical Equipment Co., Ltd 104 variants
Part of a family of 109 devices: see the family pagePart of a family of 108 devices: see the family page
Ref AZ-TF100Model AZ-SPS, AZ-ST
Splint (AZ-TF100) is a Class I device made by Anping Guardian Medical Equipment Co., Ltd, registered in EUDAMED on 9 Dec 2024 (Basic UDI-DI 697310523SPLINTPK), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697310523SPLINTPK | Date9 Dec 2024 | StatusActive |
Official records
- EUDAMED public site 697310523SPLINTPK
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- Withdrawn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
- Trade name
- Medical SplintSplint
- Model / reference
- AZ-SPS, AZ-TF100, AZ-ST
- Primary DI / UDI-DI
- 06973105232178, 06973105230143, 06973105232086
- Basic UDI-DI
- 697310523SPLINTPK, 697310523SplintFA
- EMDN code
- M03050299 Bandages and splints - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000015025
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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