Pure Global

FlareHawk Trays - EUDAMED Registration 00810045538938

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 00810045538938 and manufactured by Integrity Implants Inc. dba Accelus in United States.

This page provides complete registration details including trade name (Implant/Access Case, FH7 ), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
00810045538938
No
FlareHawk Trays
Trade Name: Implant/Access Case, FH7
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

SURGICAL INSTRUMENTS, REUSABLE - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L99
Trade Name
Implant/Access Case, FH7
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00810045538938
Basic UDI
0081000472FHTRAYSUH
Version Date
July 11, 2022
Manufacturer Last Update
July 10, 2023
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
354 Hiatt Drive Palm Beach Gardens
Email
internationalcs@accelusinc.com
Authorized Representative
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