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EUDAMED registration 00810004729285No

FlareHawk Trays

Integrity Implants Inc. dba AccelusClass IEU EUDAMEDTrade name: MIS Disc Prep Set Tray Insert - Middle
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
L99
Trade name
MIS Disc Prep Set Tray Insert - Middle
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00810004729285
Basic UDI
0081000472FHTRAYSUH
Version date
July 11, 2022
Manufacturer last update
July 10, 2023
Active status
No
Manufacturer
Manufacturer name
Integrity Implants Inc. dba Accelus
Country
United States
Country type
NON_EU
Address
354 Hiatt Drive Palm Beach Gardens
Email
internationalcs@accelusinc.com
Authorized representative
Name
MDSS GmbH
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory information
Competent authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Spain
Market available
Germany:2022-05-01~2024-05-26, Greece:2021-06-01~2024-05-26, Italy:2022-06-01~2024-05-26, Portugal:2022-06-01~2024-05-26, Spain:2021-06-01~2024-05-26
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SURGICAL INSTRUMENTS, REUSABLE - OTHER

About this record

Access comprehensive regulatory information for FlareHawk Trays 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 00810004729285 and manufactured by Integrity Implants Inc. dba Accelus in United States.

This page provides complete registration details including trade name (MIS Disc Prep Set Tray Insert - Middle ), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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.