Identity
- Trade Name
- APEX Gold 96 EUDAMED
- Device Name
- ASP GOLD EUDAMED
- Model / Reference
- 113276 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760262493534 EUDAMED
- Basic UDI-DI
- 3760262490102XT EUDAMED
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
APEX Gold 96 by Sedatelec — Class IIa — 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 | 3760262490102XT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sedatelec
- EUDAMED SRN
- FR-MF-000020946
Sources (1)
- EUDAMED 7fe46ccc-c43d-45e2-b88d-83fef9af55a0 61 fields · synced Jun 19, 2026