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Nihal
EUDAMEDClass I (EU MDR)
Ref 8906085430133Model Sterile Hypodermic Syringe without Needle Ribbon Pack
Identity
- Trade Name
- Nihal EUDAMED
- Device Name
- Sterile Hypodermic Syringe without Needle EUDAMED
- Model / Reference
- Sterile Hypodermic Syringe without Needle Ribbon Pack EUDAMED8906085430133 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906085430133 EUDAMED
- Basic UDI-DI
- 890608543SWON0150ED EUDAMED
- EMDN Code
- A020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nihal by Nihal Healthcare — 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 | 890608543SWON0150ED | Class I | Active |
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Manufacturer
- Manufacturer
- Nihal Healthcare
- EUDAMED SRN
- IN-MF-000020686
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED 410c3b86-9b2a-435c-8bb6-57ab3645ccb3 61 fields · synced Jun 19, 2026