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Disposable Tubing 18 IN (46 cm)) QTY:10
EUDAMEDClass IIa (EU MDR)
Ref 312153Model BiPAP Disposable Circuits and Accessories
Identity
- Trade Name
- Disposable Tubing 18 IN (46 cm)) QTY:10 EUDAMED
- Model / Reference
- BiPAP Disposable Circuits and Accessories EUDAMED312153 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959064690 EUDAMED
- Basic UDI-DI
- B-00606959064690 EUDAMED
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Tubing 18 IN (46 cm)) QTY:10 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-00606959064690 | 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 (2)
- EUDAMED 409884dc-5cfa-4f02-b917-8e33d81d2f34 61 fields · synced Oct 6, 2026
- EUDAMED 882beac1-07ac-4b1d-bdf6-2efb1364fd4c 61 fields · synced Aug 3, 2026