Identity
- Trade Name
- JAS GL Elbow Left EUDAMED
- Device Name
- JAS GL EUDAMED
- Model / Reference
- GL100-000-L1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810143500042 EUDAMED
- Basic UDI-DI
- 081014350GLK8 EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
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
JAS GL Elbow Left by Joint Active Systems, Inc. — Class I — 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 | 081014350GLK8 | Class I | Active |
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Manufacturer
- Manufacturer
- Joint Active Systems, Inc.
- EUDAMED SRN
- US-MF-000045774
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 8f4f5bf3-ad3a-4f2f-8998-09999dfd708b 61 fields · synced Jul 12, 2026