Identity
- Trade Name
- SAM IO ® Needle - 45mm EUDAMED
- Device Name
- SAM IO Needle EUDAMED
- Model / Reference
- IO807 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850068519330 EUDAMED
- Basic UDI-DI
- 0850068519IO70XVL EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intraosseous infusion kit
SAM IO ® Needle - 45mm by ZIEN Medical Technologies, LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0850068519IO70XVL | Class IIa | Active |
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Manufacturer
- Manufacturer
- ZIEN Medical Technologies, LLC
- EUDAMED SRN
- US-MF-000004717
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED be1a27c1-96b3-4ba9-81cf-f1f7ea44d252 61 fields · synced Jun 18, 2026