Identity
- Trade Name
- ArthroTEC EUDAMED
- Device Name
- LoopLoc - CL Fixation System EUDAMED
- Model / Reference
- AT001 EUDAMEDAT084.35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08901639070247 EUDAMED
- Basic UDI-DI
- 8901639001ATLOOPDM EUDAMED
- Direct Marketing DI
- 08901639070247 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 (1)
- EUDAMED b9121908-7f52-4e38-a449-c517daf325fc 61 fields · synced Jun 19, 2026