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Percent-O2-Lock® Assembly
EUDAMEDClass IIa (EU MDR)
Ref 8058-7-50Model Salter Oxygen Masks
by Salter Labs
Identity
- Trade Name
- Percent-O2-Lock® Assembly EUDAMED
- Model / Reference
- Salter Oxygen Masks EUDAMED8058-7-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411000345 EUDAMED
- Basic UDI-DI
- 0607411TF20014a_O2MaskLW EUDAMED
- Unit of Use DI
- 00607411000348 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Percent-O2-Lock® Assembly by Salter Labs — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0607411TF20014a_O2MaskLW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED daf21f00-3aa1-4923-8edc-68ee1e5f617c 61 fields · synced Jun 18, 2026