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Medispine
EUDAMEDClass III (EU MDR)
Ref 643018BModel Spinal needle (Quincke Bevel without Introducer Needle);Spinal needle (Pencil point without Introducer Needle);Spinal needle Pencil point with Introducer Needle
Identity
- Trade Name
- Medispine EUDAMED
- Device Name
- Spinal Needle EUDAMED
- Model / Reference
- Spinal needle (Quincke Bevel without Introducer Needle);Spinal needle (Pencil point without Introducer Needle);Spinal needle Pencil point with Introducer Needle EUDAMED643018B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545016920 EUDAMED
- Basic UDI-DI
- 8903545GMLSPN002PS EUDAMED
- EMDN Code
- A01030101 SPINAL ANAESTHESIA NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medispine by Global Medikit Limited — Class III — 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 | 8903545GMLSPN002PS | Class III | Active |
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Manufacturer
- Manufacturer
- Global Medikit Limited
- EUDAMED SRN
- IN-MF-000013635
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 13e89f32-639e-42de-8de4-81c15d9fff05 61 fields · synced Jun 9, 2026