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Dissector - EUDAMED Registration 00851085007701

Access comprehensive regulatory information for Dissector in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00851085007701 and manufactured by SI-BONE, Inc. in United States.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
00851085007701
No
Dissector
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

ORTHOPAEDIC SURGERY DISSECTORS, REUSABLE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L0926
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
00851085007701
Basic UDI
081005552Dissector3U
Version Date
February 26, 2025
Manufacturer Last Update
May 30, 2024
Active Status
No
Manufacturer
Manufacturer Name
SI-BONE, Inc.
Country
United States
Country Type
NON_EU
Address
471 El Camino Real Santa Clara, California
Email
dcher@si-bone.com
Authorized Representative
SRN
IE-AR-000006507
Country
Ireland
Address
South County Business Park Leopardstown, Dublin 18
Email
IconAR@iconplc.com
Telephone
+ 353 (1) 291 2000
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2025-03-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No