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ArthroTEC
EUDAMEDClass IIb (EU MDR)
Ref AT001.30Model AT001Ref AT001.35Ref AT010Ref AT043.03Ref AT001.20Ref AT078Ref AT001.15Ref AT084.25Ref AT043.02Ref AT084.40
by Mj Surgical
Identity
- Trade Name
- ArthroTEC EUDAMED
- Device Name
- LoopLoc - CL Fixation System EUDAMED
- Model / Reference
- AT001 EUDAMEDAT001.30 EUDAMEDAT001.35 EUDAMEDAT010 EUDAMEDAT043.03 EUDAMEDAT001.20 EUDAMEDAT078 EUDAMEDAT001.15 EUDAMEDAT084.25 EUDAMEDAT043.02 EUDAMEDAT084.40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08901639045023 EUDAMED08901639045030 EUDAMED08901639045245 EUDAMED08901639070186 EUDAMED08901639044996 EUDAMED08901639066615 EUDAMED08901639044972 EUDAMED08901639070223 EUDAMED08901639066011 EUDAMED08901639070254 EUDAMED
- Basic UDI-DI
- 8901639001ATLOOPDM EUDAMED
- Direct Marketing DI
- 08901639045023 EUDAMED08901639045030 EUDAMED08901639045245 EUDAMED08901639070186 EUDAMED08901639044996 EUDAMED08901639066615 EUDAMED08901639044972 EUDAMED08901639070223 EUDAMED08901639066011 EUDAMED08901639070254 EUDAMED
- EMDN Code
- H900301 SUTURE BUTTONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
ArthroTEC by Mj Surgical — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 8901639001ATLOOPDM | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mj Surgical
- EUDAMED SRN
- IN-MF-000008890
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (10)
- EUDAMED 87c51eae-f3ee-4bff-ba59-0d1dec5f8120 61 fields · synced Aug 3, 2026
- EUDAMED 7960b6e0-e3c9-40e4-a570-162bd3a159a3 61 fields · synced May 17, 2026
- EUDAMED 45ef4d75-5e07-47c7-ad17-61d26788b348 61 fields · synced May 17, 2026
- EUDAMED 91d4a1a8-1a47-49fa-b42f-f9203af901dc 61 fields · synced May 17, 2026
- EUDAMED 0426b2b9-83da-46ad-853c-6164581c191d 61 fields · synced May 18, 2026
- EUDAMED 42b40645-75b9-48ff-9bc8-de53506ab41b 61 fields · synced May 18, 2026
- EUDAMED 2b41906d-7aff-4651-a570-04fa43bdeef9 61 fields · synced May 19, 2026
- EUDAMED 66a69f91-7057-4a7a-a146-f87fb9de95ee 61 fields · synced May 19, 2026
- EUDAMED d7eb594f-c585-4a9b-9a0d-f4574936b524 61 fields · synced May 19, 2026
- EUDAMED cf82bb5e-2bab-4b72-a87f-d656b3396a48 61 fields · synced May 19, 2026