Identity
- Trade Name
- Deluxe Chin Strap, International EUDAMED
- Device Name
- Mask Accessory EUDAMED
- Model / Reference
- 1006085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959040243 EUDAMED
- Basic UDI-DI
- 0606959BM202LJ EUDAMED
- Direct Marketing DI
- 00606959040243 EUDAMED
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Deluxe Chin Strap, International by Respironics Inc. — Class I — 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 | 0606959BM202LJ | Class I | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (1)
- EUDAMED 2c9adc5e-e20f-41c6-8b6f-2da067ca9923 61 fields · synced Jun 19, 2026