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Safety Pen Needles
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 02-3204510(k) K210864
Identity
- Trade Name
- Safety Pen Needles EUDAMED
- Device Name
- Safety Pen Needles EUDAMED
- Model / Reference
- 02-3204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972857295131 EUDAMED
- Basic UDI-DI
- 697285729052C EUDAMED
- Unit of Use DI
- 06972857295134 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Safety Pen Needles by Sandstone Medical (suzhou) Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210864 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697285729052C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sandstone Medical(Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000011105
- FDA Applicant
- Sandstone Medical (Suzhou), Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4fe20749-8404-4329-8d6b-851d5ad7871c 85 fields · synced Jun 18, 2026
- FDA 510(k) K210864 1 fields · synced May 18, 2026