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Menix®
EUDAMEDFDA UDIClass I (EU MDR)
Ref MEN9000408Model Metal instrumentRef MEN9000402Model Twister
by S.b.m. Sas
Identity
- Trade Name
- MENIX® EUDAMEDMENIX FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDIEndoscopic surgical probe FDA UDI
- Device Name
- Metal instrument for meniscus repair EUDAMEDTwister for meniscus repair EUDAMEDMENIX Twister to be used with MENIX and MENIX DUO devices in meniscal repair. FDA UDIMENIX 90 degree probe to be used with MENIX and MENIX DUO devices in meniscal repair. FDA UDI
- Model / Reference
- Metal instrument EUDAMEDMEN9000408 EUDAMEDTwister EUDAMEDMEN9000402 EUDAMEDMENIX Twister FDA UDIMENIX 90 degree probe FDA UDI
- Description
- MENIX Twister to be used with MENIX and MENIX DUO devices in meniscal repair. FDA UDIMENIX 90 degree probe to be used with MENIX and MENIX DUO devices in meniscal repair. FDA UDI
Identifiers
- Catalog Number
- MEN9000402 FDA UDIMEN9000408 FDA UDI
- Primary DI / UDI-DI
- 03760304680755 EUDAMEDFDA UDI03760304680731 EUDAMEDFDA UDI
- Basic UDI-DI
- 376015400DT2020021TP EUDAMED376015400DT2020022TR EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDIEndoscopic surgical probe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France EUDAMEDSpain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant template, reusable
Menix® by S.b.m. Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376015400DT2020021TP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.b.m. Sas
- EUDAMED SRN
- FR-MF-000000214
Sources (4)
- EUDAMED 154447a0-83ed-4387-93e7-9d63a03f0383 61 fields · synced Jul 31, 2026
- FDA UDI 226d45fa-67b4-4250-b2ab-8f30376c02cd 34 fields · synced May 30, 2026
- FDA UDI 4ff0a974-d7ec-4bae-b756-c780d23c3725 34 fields · synced May 30, 2026
- EUDAMED db787f56-97f1-4a0b-bcca-9262355cece5 61 fields · synced Jul 31, 2026