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Trilogy Evo, Germany
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DE2110X13BModel Trilogy Evo, Germany
Identity
- Trade Name
- Trilogy Evo, Germany EUDAMEDTrilogy FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy Evo Ventilator System, Germany FDA UDI
- Model / Reference
- Trilogy Evo, Germany EUDAMEDDE2110X13B EUDAMEDTrilogy Evo Ventilator, Germany FDA UDI
- Description
- Trilogy Evo Ventilator System, Germany FDA UDI
Identifiers
- Catalog Number
- DE2110X13B FDA UDI
- Primary DI / UDI-DI
- 00606959054110 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959054110 EUDAMED
- FDA Product Code
- CCK FDA UDICBK FDA UDINOU FDA UDIDQA FDA UDI
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 FDA UDI868.5895 FDA UDI870.2700 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
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
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 Evo, 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-00606959054110 | 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 3d8f8560-149e-41f8-9da3-2640a77cabfe 61 fields · synced Jun 20, 2026
- FDA UDI ec095356-114e-466d-b9de-8f20a807b3c6 35 fields · synced May 29, 2026
- EUDAMED 5feeea3a-915e-4621-a4b5-830adced4342 61 fields · synced Jun 20, 2026