IMS Type IIR Splash Resistant Surgical Mask (Ear Loop and Nose Bridge)
by Shandong Intco Medical Products Co., Ltd.
Ref IMS71000R2
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 06978719515440 | 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- Withdrawn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
- IMS71000R2
- Primary DI / UDI-DI
- 06978719515440
- Basic UDI-DI
- 697024575FMYN
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU 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.
See all devices from Shandong Intco Medical Products 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