IMS Disposable Face Masks
by Shandong Intco Medical Products Co., Ltd.
Ref IMS71000E
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 | Number697024575FMYN 06978719515457 | Date5 Dec 2023 | 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- Withdrawn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
- Medical Face Mask
- Model / Reference
- IMS71000E
- Primary DI / UDI-DI
- 06978719515457
- Basic UDI-DI
- 697024575FMYN
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000002100
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shandong Intco Medical Products 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