Identity
- Trade Name
- ArthroTEC EUDAMED
- Device Name
- LoopLoc - CL Fixation System EUDAMED
- Model / Reference
- AT001 EUDAMEDAT001.25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08901639045016 EUDAMED
- Basic UDI-DI
- 8901639001ATLOOPDM 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
Category: Tendon/ligament bone anchor, non-bioabsorbable
ArthroTEC by Mj Surgical — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
- FLIPTIGHT LOOP — RIVERPOINT MEDICAL LLC · Class II
- Ecobone — Bonegraft Biomaterials Co. · Class III
- fX — Bonegraft Biomaterials Co. · Class III
- GII PANACRYL — DePuy Mitek, Inc. · Class II
- Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
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 98b18506-728b-4a9f-8065-75939143151e 61 fields · synced Jun 19, 2026