Identity
- Trade Name
- TNI softFlow 50 clinic EUDAMEDsoftFlow FDA UDI
- Generic Name
- Professional high-flow respiratory unit, humidifying, manual FDA UDI
- Device Name
- TNI softFlow 50 clinic EUDAMEDTNI softFlow 50 FDA UDI
- Model / Reference
- 40610021 EUDAMEDFDA UDI
- Description
- TNI softFlow 50 FDA UDI
Identifiers
- Catalog Number
- 40610021 FDA UDI
- Primary DI / UDI-DI
- 04059163000415 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04059163000415 EUDAMED
- FDA Product Code
- BTT FDA UDI
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
- GMDN Term
- Professional high-flow respiratory unit, humidifying, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5450 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Professional high-flow respiratory unit, humidifying, manual
softFlow by Tni Medical AG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Professional high-flow respiratory unit, humidifying, manual.
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Vapotherm — Vapotherm Inc. · Class II
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- Vapotherm — Vapotherm Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tni Medical AG
Sources (2)
- FDA UDI cb885f8b-b71d-4bb7-8a7b-46464e56b456 36 fields · synced Jul 25, 2026
- EUDAMED c000f60d-c3dc-4287-9da3-9706da67f03f 61 fields · synced Jul 25, 2026