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Hypodermic Needles - Safety needle
EUDAMEDClass IIa (EU MDR)
Ref 20IN-0000202502
Identity
- Device Name
- Hypodermic Needles - Safety needle EUDAMED
- Model / Reference
- 20IN-0000202502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699207501209 EUDAMED
- Basic UDI-DI
- 8699207STSHNGS EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hypodermic needle, single-use
Hypodermic Needles - Safety needle by Set Medikal Sanayi ve Ticaret A.S - MF — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hypodermic needle, single-use.
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- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
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 | 8699207STSHNGS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Set Medikal Sanayi ve Ticaret A.S - MF
- EUDAMED SRN
- TR-MF-000028280
Sources (1)
- EUDAMED 40f20204-480e-435f-b020-5f4df8a0dbe6 61 fields · synced Jun 18, 2026