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Trilogy 100 Ventilator, INTL — Bluetooth
EUDAMEDClass IIb (EU MDR)
Ref 1054096BModel Trilogy 100
Identity
- Trade Name
- Trilogy 100 Ventilator, INTL — Bluetooth EUDAMED
- Device Name
- Trilogy 100 EUDAMED
- Model / Reference
- Trilogy 100 EUDAMED1054096B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959429246 EUDAMED
- Basic UDI-DI
- B-00606959429246 EUDAMED
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb 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
Trilogy 100 Ventilator, INTL — Bluetooth by Respironics, Inc. — Class IIb — 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-00606959429246 | Class IIb | 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 (1)
- EUDAMED e3651673-164d-4063-a6d6-445d14472677 61 fields · synced Jun 17, 2026