Identity
- Trade Name
- Pen Needles EUDAMED
- Device Name
- Pen Needles EUDAMED
- Model / Reference
- HAR3204 32G×4mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972857292802 EUDAMED
- Basic UDI-DI
- 6972857290124 EUDAMED
- Unit of Use DI
- 06972857292805 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
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 | 6972857290124 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sandstone Medical(Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000011105
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c6668aec-b109-45c9-a03f-d33d020bf380 61 fields · synced May 29, 2026