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Needle Guidance System
EUDAMEDClass IIa (EU MDR)
Ref H48062AS
by CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
Identity
- Trade Name
- Needle Guidance System EUDAMED
- Device Name
- General Purpose Guidance – Out-of-Plane, Fixed Angle (Accusite guide) EUDAMED
- Model / Reference
- H48062AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841436125840 EUDAMED
- Basic UDI-DI
- 0841436101TD101B1NA EUDAMED
- Direct Marketing DI
- 20841436125530 EUDAMED
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Needle Guidance System by CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions — Class IIa — MDR — listed in EUDAMED
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 | 0841436101TD101B1NA | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- US-MF-000008229
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 3e1fb079-c8f2-41d9-8197-c24147fac970 61 fields · synced Oct 6, 2026