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Recert-Trilogy 100 Vent, Germany -BT
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref U1054097B
Identity
- Trade Name
- Recert-Trilogy 100 Vent,Germany -BT EUDAMEDTrilogy FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy 100, Trilogy EC EUDAMEDTrilogy 100 Ventilator with Bluetooth, Recertified, Germany FDA UDI
- Model / Reference
- U1054097B EUDAMEDFDA UDI
- Description
- Trilogy 100 Ventilator with Bluetooth, Recertified, Germany FDA UDI
Identifiers
- Catalog Number
- U1054097B FDA UDI
- Primary DI / UDI-DI
- 00606959028937 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959028937 EUDAMED
- FDA Product Code
- CBK FDA UDINOU 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 II FDA UDI
- Regulation Number
- 868.5895 FDA UDI870.2700 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
Recert-Trilogy 100 Vent, Germany -BT 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-00606959028937 | 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 809a8310-7eff-434e-985b-481febde6188 61 fields · synced Jul 28, 2026
- FDA UDI bc92ae79-2023-4e6f-bbfa-86d047fd6dd1 36 fields · synced May 29, 2026
- EUDAMED b0c3e78b-06e1-4266-a709-95c057a5ed22 61 fields · synced Jul 28, 2026