Identity
- Device Name
- Flex-Guard Mesh Arm Trap EUDAMED
- Model / Reference
- A-21200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848340018046 EUDAMED
- Basic UDI-DI
- B-00848340018046 EUDAMED
- EMDN Code
- Z12130285 ORTHOPAEDIC TRACTION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Flex-Guard Mesh Arm Trap by Advance Medical Designs, Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00848340018046 | Class I | Active |
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Manufacturer
- Manufacturer
- Advance Medical Designs, Inc.
- EUDAMED SRN
- US-MF-000009790
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 73844a18-2160-44a2-8560-fd10c5523566 61 fields · synced Oct 6, 2026