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Accu-PRO NIBP Cuff, Disposable - EUDAMED Registration 25060179637161

Access comprehensive regulatory information for Accu-PRO NIBP Cuff, Disposable 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 25060179637161 and manufactured by PROACT Medical Ltd. in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Accu-PRO NIBP Cuff, Disposable, Single Tube, No Connector, Neonate 3), 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
25060179637161
No
Accu-PRO NIBP Cuff, Disposable
Trade Name: Accu-PRO NIBP Cuff, Disposable, Single Tube, No Connector, Neonate 3
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Device Description (EMDN)

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12040180
Trade Name
Accu-PRO NIBP Cuff, Disposable, Single Tube, No Connector, Neonate 3
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
25060179637161
Basic UDI
50560945APCDLB
Active Status
No
Manufacturer
Manufacturer Name
PROACT Medical Ltd.
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
9-13 Oakley Hay Lodge Corby
Email
quality@proactmedical.co.uk
Authorized Representative
SRN
IE-AR-000000592
Country
Ireland
Address
Knockmorris Co. Tipperary
Email
prrc@acornregulatory.com
Telephone
+ 353 52 6176706
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
Ireland
Device Characteristics
Human Tissues
No
Animal Tissues
No