Self Sealing Sterilization Pouches/Reels
by Wellmed Dental Medical Supply Co., Ltd 51 variants
Ref IS-002
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 | Number697460865IS-002H2 | Date6 May 2026 | 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- Withdrawn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
- Self Sealing Sterilization Pouches/Reels
- Model / Reference
- IS-002
- Primary DI / UDI-DI
- 16974608655843, 06974608655846
- Basic UDI-DI
- 697460865IS-002H2
- EMDN Code
- S010299 Sterilisation reels - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000003243
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wellmed Dental Medical Supply Co., Ltd
See all devices from Wellmed Dental Medical Supply Co., Ltd →
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