Identity
- Trade Name
- VenoTrain soft S, AD, border dot 3cm, Ccl 1, Special heel, closed toe, M Plus short, Black EUDAMEDVenoTrain soft S FDA UDI
- Generic Name
- Compression/pressure sock/stocking, single-use FDA UDI
- Device Name
- VenoTrain soft S EUDAMED
- Model / Reference
- 21280411704322 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057532418229 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 by Bauerfeind GmbH & Co. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure sock/stocking, single-use.
- JOBST Relief — BSN MEDICAL, INC. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- JOBST Relief — BSN MEDICAL, INC. · Class II
- VenoTrain soft, AG, Top band silicone micro dots, Ccl2, open toe, L Plus short, Cream — Bauerfeind AG · Class I
- VARISAN TOP COTTON — CIZETA MEDICALI S.P.A. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class II
- Juzo Soft Silver — JULIUS ZORN, INC. · Class I
Cleared under the same submission
K860826 also covers:
- VenoTrain discrétion — Bauerfeind GmbH & Co.
- VenoTrain discrétion — Bauerfeind GmbH & Co.
- VenoTrain discrétion — Bauerfeind GmbH & Co.
- VenoTrain impuls — Bauerfeind GmbH & Co.
- VenoTrain look — Bauerfeind GmbH & Co.
- VenoTrain look — Bauerfeind GmbH & Co.
- VenoTrain micro — Bauerfeind GmbH & Co.
- VenoTrain micro — Bauerfeind GmbH & Co.
- VenoTrain micro — Bauerfeind GmbH & Co.
- VenoTrain micro — Bauerfeind GmbH & Co.
- VenoTrain micro — Bauerfeind GmbH & Co.
- VenoTrain micro — Bauerfeind GmbH & Co.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bauerfeind GmbH & Co.
Sources (2)
- FDA UDI 93088a4b-6887-4d20-83b1-1d45a0efff29 33 fields · synced Jun 18, 2026
- EUDAMED 5d6130e5-7e95-4c27-8e21-f139240b63f6 61 fields · synced Jun 18, 2026