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Easydrip Pen Needles
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 04-3105Model Plus Pro510(k) K193422
Identity
- Trade Name
- Easydrip Pen Needles EUDAMED
- Device Name
- Pen Needles EUDAMED
- Model / Reference
- Plus Pro EUDAMED04-3105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972857294882 EUDAMED
- Basic UDI-DI
- 697285729042A EUDAMED
- Unit of Use DI
- 06972857294885 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Easydrip 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 | K193422 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697285729042A | 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 bd5acae8-1a89-4435-b3be-d6e0604f5373 85 fields · synced Jun 18, 2026
- FDA 510(k) K193422 1 fields · synced May 18, 2026