Spreaders
by Shanwei Perfect Medical Instruments Co., Ltd. 117 variants
Ref SSS,010 002Model Pluggers(SS304)、Spreaders(SS304)
Spreaders (SSS,010 002) is a Class I device made by Shanwei Perfect Medical Instruments Co., Ltd., registered in EUDAMED on 16 May 2026 (Basic UDI-DI 697590932SSTCompactorS9), active as of 7 Nov 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 | Number697590932SSTCompactorS9 06942200900541 | Date16 May 2026 | StatusActive |
Official records
- EUDAMED public site 697590932SSTCompactorS9
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- Withdrawn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
- Dental Root-Canal Instruments
- Model / reference
- Pluggers(SS304)、Spreaders(SS304), SSS, 010 002
- Primary DI / UDI-DI
- 06942200900541
- Basic UDI-DI
- 697590932SSTCompactorS9
- EMDN code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000033003
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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