Identity
- Trade Name
- MONO CL.2 Cotton DX 5° EUDAMED
- Device Name
- CLASSE 2 Cotton EUDAMED
- Model / Reference
- 8053685729522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053685729522 EUDAMED
- Basic UDI-DI
- 805368572434308CK2S3 EUDAMED
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Compression/pressure sock/stocking, single-use
MONO CL.2 Cotton DX 5° by New Medical Service Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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
- VenoTrain soft, AG, Top band silicone micro dots, Ccl2, open toe, L Plus short, Cream — Bauerfeind AG · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805368572434308CK2S3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- New Medical Service Srl
- EUDAMED SRN
- IT-MF-000034543
Sources (1)
- EUDAMED d64756bc-fe01-417c-a494-714604b6f93c 61 fields · synced Jul 25, 2026