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Biopsy Guidance - EUDAMED Registration 00884838118492

Access comprehensive regulatory information for Biopsy Guidance 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 00884838118492 and manufactured by Invivo Corporation in United States.

This page provides complete registration details including trade name (MRI Needle Block 14G), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
00884838118492
No
Biopsy Guidance
Trade Name: MRI Needle Block 14G
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Device Description (EMDN)

NEEDLE GUIDES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
A018002
Trade Name
MRI Needle Block 14G
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00884838118492
Basic UDI
0884838BM421SN
Version Date
February 07, 2025
Manufacturer Last Update
June 05, 2024
Active Status
No
Manufacturer
Manufacturer Name
Invivo Corporation
Country
United States
Country Type
NON_EU
Address
3545 SW 47th Ave Gainesville
Email
eudamed@philips.com
Authorized Representative
SRN
NL-AR-000001422
Country
Netherlands
Address
6 Veenpluis Best
Email
EU.Auth.Rep@philips.com
Telephone
n/a
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Market Available
Netherlands:2024-07-25~9999-12-31, Austria:2024-07-25~9999-12-31, Belgium:2024-07-25~9999-12-31, Bulgaria:2024-07-25~9999-12-31, Cyprus:2024-07-25~9999-12-31, Germany:2024-07-25~9999-12-31, Denmark:2024-07-25~9999-12-31, Finland:2024-07-25~9999-12-31, Ireland:2024-07-25~9999-12-31, Iceland:2024-07-25~9999-12-31, Liechtenstein:2024-07-25~9999-12-31, Luxembourg:2024-07-25~9999-12-31, Malta:2024-07-25~9999-12-31, Norway:2024-07-25~9999-12-31, Sweden:2024-07-25~9999-12-31, Slovenia:2024-07-25~9999-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No