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IMS Type IIR Splash Resistant Surgical Mask (Tie-On and Nose Bridge)
EUDAMEDClass I (EU MDR)
Ref IMS71000
Identity
- Trade Name
- IMS Type IIR Splash Resistant Surgical Mask (Tie-On and Nose Bridge) EUDAMED
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- IMS71000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978719515464 EUDAMED
- Basic UDI-DI
- 697024575FMYN EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IMS Type IIR Splash Resistant Surgical Mask (Tie-On and Nose Bridge) by Shandong Intco Medical Products Co., Ltd. — Class I — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697024575FMYN | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Intco Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000002100
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c4ce8f8b-c290-4366-b02a-5055e3cfaf28 61 fields · synced Oct 7, 2026