Identity
- Trade Name
- Trilogy100 Ventilator, Germany EUDAMEDTrilogy FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy 100, Trilogy EC EUDAMEDTrilogy 100 Ventilator, Germany FDA UDI
- Model / Reference
- 1054097 EUDAMEDTrilogy100 Ventilator, Germany FDA UDI
- Description
- Trilogy 100 Ventilator, Germany FDA UDI
Identifiers
- Catalog Number
- 1054097 FDA UDI
- Primary DI / UDI-DI
- 00606959022751 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959022751 EUDAMED
- 510(k) Number
- K083526 FDA UDI
- FDA Product Code
- DQA FDA UDINOU FDA UDICBK 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 UDI
- Market of Registration
- Germany 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
Trilogy100 Ventilator, Germany 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-00606959022751 | 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 (2)
- EUDAMED d4359b21-aefa-4a14-837b-a09faa5fb704 61 fields · synced Jun 17, 2026
- FDA UDI e2eb4ddf-1db9-4756-afab-d021ddaa9361 37 fields · synced May 30, 2026