Identity
- Trade Name
- PN841, INTL, Child Large, Leak 3, 5 Pack EUDAMED
- Device Name
- PN841, INTL, Child Large, Leak 3, 5 Pack EUDAMED
- Model / Reference
- 1130581 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30606959041746 EUDAMED
- Basic UDI-DI
- B-30606959041746 EUDAMED
- EMDN Code
- R0301010201 CPAP 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
PN841, INTL, Child Large, Leak 3, 5 Pack by Respironics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-30606959041746 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (1)
- EUDAMED c7658029-317f-4435-995f-fee93f6924f2 61 fields · synced Aug 1, 2026