Identity
- Device Name
- Needle Grid 17G-18G EUDAMED
- Model / Reference
- KSU.EL4.18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848340017902 EUDAMED
- Basic UDI-DI
- 84834000KSU.EL4.18K2 EUDAMED
- EMDN Code
- A018002 NEEDLE GUIDES 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
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
Needle Grid 17G-18G by Advance Medical Designs, 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 | 84834000KSU.EL4.18K2 | 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 b46798fd-3556-4e5a-ac2b-c29a13ba8dd6 61 fields · synced Oct 7, 2026