VenoTrain soft S, AD, Ccl 1, Special heel, closed toe, XS Normal short, Amaretto
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- VenoTrain soft S, AD, Ccl 1, Special heel, closed toe, XS Normal short, Amaretto EUDAMEDVenoTrain soft S FDA UDI
- Generic Name
- Compression/pressure sock/stocking, single-use FDA UDI
- Device Name
- VenoTrain soft S EUDAMED
- Model / Reference
- 21280011404220 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057532497675 EUDAMEDFDA UDI
- Basic UDI-DI
- 4046445SOFs00000005D EUDAMED
- 510(k) Number
- K860826 FDA UDI
- FDA Product Code
- DWL FDA UDI
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
- GMDN Term
- Compression/pressure sock/stocking, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5780 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Compression/pressure sock/stocking, single-use
VenoTrain soft S, AD, Ccl 1, Special heel, closed toe, XS Normal short, Amaretto by Bauerfeind AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Compression/pressure sock/stocking, single-use.
- JOBST Relief — BSN MEDICAL, INC. · Class II
- VenoTrain soft — Bauerfeind GmbH & Co. · Class II
- VenoTrain soft S — Bauerfeind GmbH & Co. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- JOBST Relief — BSN MEDICAL, INC. · Class II
- VenoTrain micro — Bauerfeind GmbH & Co. · Class II
- VARISAN TOP COTTON — CIZETA MEDICALI S.P.A. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4046445SOFs00000005D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bauerfeind AG
- EUDAMED SRN
- DE-MF-000007543
Sources (2)
- EUDAMED 847144a8-267c-4a6f-b1f2-84df2e4a2512 61 fields · synced Jul 16, 2026
- FDA UDI 6ab01eb8-25b2-40cb-8652-985c4c133b42 33 fields · synced May 30, 2026