Identity
- Trade Name
- Applicator Clinic Standard EUDAMEDsoftFlow FDA UDI
- Generic Name
- Inspiratory line humidification chamber, single-use FDA UDI
- Device Name
- Applicator Clinic Standard Plus EUDAMEDApplicator Clinic Std.-Plus softFlow 50 FDA UDI
- Model / Reference
- 40630005 EUDAMEDFDA UDI
- Description
- Applicator Clinic Std.-Plus softFlow 50 FDA UDI
Identifiers
- Catalog Number
- 40630005 FDA UDI
- Primary DI / UDI-DI
- 04059163000064 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04059163000064 EUDAMED
- FDA Product Code
- BTT FDA UDI
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
- GMDN Term
- Inspiratory line humidification chamber, single-use 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Inspiratory line humidification chamber, single-use
softFlow by Tni Medical AG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Tni Medical AG
Sources (2)
- FDA UDI ddbc96a0-f543-4b51-ad0d-a5b6c61f845a 36 fields · synced Jun 20, 2026
- EUDAMED 36d251cf-e8bc-4dde-bd5e-10b6ded6a3f4 61 fields · synced Jun 20, 2026