Identity
- Trade Name
- Safety Pen Needles EUDAMED
- Device Name
- Safety Pen Needles EUDAMED
- Model / Reference
- 03-3108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972857295124 EUDAMED
- Basic UDI-DI
- 697285729052C EUDAMED
- Unit of Use DI
- 06972857295127 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 — 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 | 697285729052C | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sandstone Medical(Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000011105
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED df850dac-36f6-48e7-8913-ec6ed99b0362 61 fields · synced May 29, 2026