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Trilogy100 Ventilator, Bluetooth, Italy
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IT1054096B
Identity
- Trade Name
- Trilogy100 Ventilator, Bluetooth, Italy EUDAMEDTrilogy 100 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy 100, Trilogy EC EUDAMEDTrilogy 100 Ventilator, withBluetooth, Italy FDA UDI
- Model / Reference
- IT1054096B EUDAMEDTrilogy100 Ventilator, Bluetooth, Italy FDA UDI
- Description
- Trilogy 100 Ventilator, withBluetooth, Italy FDA UDI
Identifiers
- Catalog Number
- IT1054096B FDA UDI
- Primary DI / UDI-DI
- 00606959042933 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959042933 EUDAMED
- 510(k) Number
- K083526 FDA UDI
- FDA Product Code
- OUG FDA UDICBK FDA UDIDQA 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 I FDA UDI
- Regulation Number
- 880.6310 FDA UDI868.5895 FDA UDI870.2700 FDA UDI
- Market of Registration
- Italy 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, Bluetooth, Italy 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-00606959042933 | 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 e8449c3f-097a-4283-82b2-184a831cfc5f 61 fields · synced Jun 18, 2026
- FDA UDI 7f24a019-285c-4fff-94c2-ad9a308563c4 37 fields · synced May 29, 2026