Identity
- Trade Name
- 85630 EUDAMED
- Device Name
- 85630 EUDAMED
- Model / Reference
- ENDOKIT EUDAMED85630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760392530161 EUDAMED
- Basic UDI-DI
- B-03760392530161 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Category: Gastro-urological guidewire, single-use
85630 by Advance Medical Integration Systems — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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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-03760392530161 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advance Medical Integration Systems
- EUDAMED SRN
- FR-MF-000014717
Sources (1)
- EUDAMED 5a04a6f6-4698-486f-8bbe-be94926b887e 61 fields · synced Jul 11, 2026