Identity
- Trade Name
- SOL-CARE Safety Needle EUDAMED
- Device Name
- SOL-CARE Safety Needle EUDAMED
- Model / Reference
- Safety Needle EUDAMEDSN2105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818392012620 EUDAMED
- Basic UDI-DI
- 081006243SND12E EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Category: Hypodermic needle, single-use
SOL-CARE Safety Needle by Sol-Millennium Medical, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 081006243SND12E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sol-Millennium Medical, Inc.
- EUDAMED SRN
- US-MF-000010890
- Authorised Representative
- Sol-Millennium Europe Sp. z o.o. PL-AR-000010397
Sources (1)
- EUDAMED 6977dea2-ef06-48fa-9da2-3543778923cc 61 fields · synced Jun 9, 2026