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I-Guard Aerosol Mask (Pediatric), elastic strap fixation
EUDAMEDClass IIb (EU MDR)
Ref 1107-0-50Model Salter Labs Aerosol Masks
by Salter Labs
Identity
- Trade Name
- I-Guard Aerosol Mask (Pediatric), elastic strap fixation EUDAMED
- Model / Reference
- Salter Labs Aerosol Masks EUDAMED1107-0-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20607411800874 EUDAMED
- Basic UDI-DI
- 0607411TF20013aAersMaskM5 EUDAMED
- Unit of Use DI
- 00607411800870 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
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
I-Guard Aerosol Mask (Pediatric), 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 (1)
- EUDAMED 14ea7a70-0028-47d5-a4f2-edd5988c8377 61 fields · synced Jul 24, 2026