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SOL-CARE Safety Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SN2158Model Safety Needle
Identity
- Trade Name
- SOL-CARE Safety Needle EUDAMEDSOL-CARE™ Safety Needle FDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- SOL-CARE Safety Needle EUDAMEDThe SOL-CARE™ Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules, and parts of the body below the surface of the skin. 21g x 5/8" safety needle FDA UDI
- Model / Reference
- Safety Needle EUDAMEDSN2158 EUDAMEDFDA UDI
- Description
- The SOL-CARE™ Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules, and parts of the body below the surface of the skin. 21g x 5/8" safety needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818392010565 EUDAMEDFDA UDI
- Basic UDI-DI
- 081006243SND12E EUDAMED
- Direct Marketing DI
- 00818392010565 EUDAMED
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 21 Gauge FDA UDILength — 16 Millimeter FDA UDI
Category: Hypodermic needle, single-use
SOL-CARE Safety Needle by Sol-Millennium Medical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
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- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081006243SND12E | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED c2c0741d-cd1f-4faa-a0c2-d171232acb65 61 fields · synced Jun 9, 2026
- FDA UDI cc076ce9-f8f2-4cf3-ae27-9a8754211797 35 fields · synced May 30, 2026