Innomed
by Zhejiang Longterm Medical Technology Co., Ltd. 275 variants
Ref SM-03SModel SM-01S
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69263655100157Q 06926365581531 | Date18 Jul 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Surgical mask
- Model / Reference
- SM-01S, SM-03S
- Primary DI / UDI-DI
- 06926365581531
- Basic UDI-DI
- 69263655100157Q
- Direct Marketing DI
- 06926365581531
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000001161
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Zhejiang Longterm Medical Technology Co., Ltd.
See all devices from Zhejiang Longterm Medical Technology Co., Ltd. →
Properties
Other properties (12)
- 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