← Back to catalogue
Trilogy 200 Ventilator, Intl-Recert
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref U1032800
Identity
- Trade Name
- Trilogy 200 Ventilator, Intl-Recert EUDAMEDTrilogy 200 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy 200 EUDAMEDTrilogy 200 Ventilator, Recertified, International version FDA UDI
- Model / Reference
- U1032800 EUDAMEDTrilogy 200 Ventilator, Intl-Recert FDA UDI
- Description
- Trilogy 200 Ventilator, Recertified, International version FDA UDI
Identifiers
- Catalog Number
- U1032800 FDA UDI
- Primary DI / UDI-DI
- 00606959033917 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959033917 EUDAMED
- 510(k) Number
- K093416 FDA UDI
- FDA Product Code
- DQA FDA UDICBK FDA UDIOUG 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
- 870.2700 FDA UDI868.5895 FDA UDI880.6310 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
Trilogy 200 Ventilator, Intl-Recert 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-00606959033917 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 21f5bdb9-4455-4654-8818-36af97b7072d 61 fields · synced Jun 18, 2026
- FDA UDI fec844db-354e-4c86-b03b-c89602c7f178 37 fields · synced May 30, 2026