Identity
- Device Name
- PEP/Rmt mask EUDAMED
- Model / Reference
- 71110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07395502099502 EUDAMED
- Basic UDI-DI
- 73955026115152BN5 EUDAMED
- Direct Marketing DI
- 07395502099502 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Category: Anaesthesia face mask, single-use
PEP/Rmt mask by Mediplast AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 73955026115152BN5 | Class I | Active |
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Manufacturer
- Manufacturer
- Mediplast AB
- EUDAMED SRN
- SE-MF-000000885
Sources (1)
- EUDAMED 0cb7de40-94e9-464f-9571-5b0f91061975 61 fields · synced Jun 19, 2026