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Aerosol Mask (Adult), elastic strap fixation
EUDAMEDClass IIb (EU MDR)
Ref 1100-0-50Model Salter Labs Aerosol MasksRef 8100-0-50
by Salter Labs
Identity
- Trade Name
- Aerosol Mask (Adult), elastic strap fixation EUDAMED
- Model / Reference
- Salter Labs Aerosol Masks EUDAMED1100-0-50 EUDAMED8100-0-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411301145 EUDAMED10607411800266 EUDAMED
- Basic UDI-DI
- 0607411TF20013aAersMaskM5 EUDAMED
- Unit of Use DI
- 00607411301148 EUDAMED00607411800269 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIb 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
Aerosol Mask (Adult), elastic strap fixation by Salter Labs — Class IIb — 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 | 0607411TF20013aAersMaskM5 | Class IIb | 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 (2)
- EUDAMED 70da81c9-d550-42e7-83ce-dbbdaaa4fe34 61 fields · synced Jul 8, 2026
- EUDAMED 64ebf51d-e945-46a0-9445-1d4aa05cb74d 61 fields · synced May 18, 2026