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Osteotome - EUDAMED Registration 00840277131614

Access comprehensive regulatory information for Osteotome 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 00840277131614 and manufactured by Innomed, Inc. in United States.

This page provides complete registration details including trade name (Offset Osteotome Blade 15mm), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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
00840277131614
No
Osteotome
Trade Name: Offset Osteotome Blade 15mm
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Device Description (EMDN)

ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L090401
Trade Name
Offset Osteotome Blade 15mm
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
00840277131614
Basic UDI
8402771INNOOSTEO016V
Version Date
February 05, 2025
Manufacturer Last Update
October 22, 2021
Active Status
No
Manufacturer
Manufacturer Name
Innomed, Inc.
Country
United States
Country Type
NON_EU
Address
103 Estus Drive Savannah
Email
irene@innomed.net
Authorized Representative
SRN
FR-AR-000000182
Country
France
Address
11 RUE EMILE ZOLA GRENOBLE
Email
info@medimark-europe.com
Telephone
+33 4 76 86 43 22
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No