Identity
- Trade Name
- BiPAP A30 Ventilator, INTL EUDAMEDBiPAP A30 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- BiPAP A30 EUDAMEDBiPAP A30, International FDA UDI
- Model / Reference
- 1111143 EUDAMEDBiPAP A30 Ventilator, INTL FDA UDI
- Description
- BiPAP A30, International FDA UDI
Identifiers
- Catalog Number
- 1111143 FDA UDI
- Primary DI / UDI-DI
- 00606959067493 EUDAMED00606959039308 FDA UDI
- Basic UDI-DI
- B-00606959067493 EUDAMED
- 510(k) Number
- K113053 FDA UDI
- FDA Product Code
- MNS FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BiPAP A30 Ventilator, INTL by Respironics, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959067493 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED ccaa75bf-3c4b-4856-ba1d-28341622a85e 61 fields · synced Jun 19, 2026
- FDA UDI f4a36203-0801-4161-9291-18c647db5c33 37 fields · synced May 30, 2026
- EUDAMED 8ee777ad-d19b-42b3-b624-bf8614682482 61 fields · synced Jun 19, 2026