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Linx
EUDAMEDClass IIb (EU MDR)
Ref LXM15Ref LXM16Ref LSS-2Ref LXM14Ref LXM17Ref LST
Identity
- Trade Name
- LINX EUDAMED
- Generic Name
- GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES EUDAMED
- Model / Reference
- LXM15 EUDAMEDLXM16 EUDAMEDLSS-2 EUDAMEDLXM14 EUDAMEDLXM17 EUDAMEDLST EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000013107000074MQ EUDAMEDD-USMF000013107000075MS EUDAMEDD-USMF000013107000071MJ EUDAMEDD-USMF000013107000073MN EUDAMEDD-USMF000013107000076MU EUDAMEDD-USMF000013107000070MG EUDAMED
- Basic UDI-DI
- B-USMF000013107000074MQ EUDAMEDB-USMF000013107000075MS EUDAMEDB-USMF000013107000071MJ EUDAMEDB-USMF000013107000073MN EUDAMEDB-USMF000013107000076MU EUDAMEDB-USMF000013107000070MG EUDAMED
- EMDN Code
- P050101 GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESES EUDAMEDP058001 OESOPHAGEAL AND GASTROINTESTINAL PROSTHESES POSITIONING DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Legislation / Framework
- MDD (Directive 93/42/EEC on Medical Devices) EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
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
Linx by Torax Medical, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000013107000074MQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Torax Medical, Inc.
- EUDAMED SRN
- US-MF-000016782
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (6)
- EUDAMED e48139d4-655a-4d20-b626-8544c05b3e45 61 fields · synced Aug 4, 2026
- EUDAMED 80e7f64d-961a-4ea8-b761-7a8d05035345 68 fields · synced May 11, 2026
- EUDAMED f0222fcb-18cd-47bc-b5ec-8bc5c8f77c39 61 fields · synced Jul 17, 2026
- EUDAMED 0b9ae237-83f1-4955-861c-ba52c9d3f6a0 61 fields · synced Jul 20, 2026
- EUDAMED caf05d06-a092-4c25-94a3-e994714afe97 61 fields · synced Aug 2, 2026
- EUDAMED d51a708b-c600-48b5-b292-4149c169c4c5 61 fields · synced Aug 4, 2026