Pure Global

Ammi CRYSTAL - EUDAMED Registration 08809639781401

Access comprehensive regulatory information for Ammi CRYSTAL in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 08809639781401 and manufactured by BioPlus Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (Ammi CRYSTAL), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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 III
08809639781401
No
Ammi CRYSTAL
Trade Name: Ammi CRYSTAL
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

RESORBABLE FILLING AND RECONSTRUCTION DEVICES

Device Classification
Risk Class
Class III
CND Nomenclatures Code
P900402
Trade Name
Ammi CRYSTAL
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08809639781401
Basic UDI
B-08809639781401
Version Date
February 13, 2024
Manufacturer Last Update
September 25, 2023
Active Status
No
Manufacturer
Manufacturer Name
BioPlus Co., Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
14 Sagimakgol-ro 45beon-gil Seongnam-si
Email
info@ubioplus.com
Authorized Representative
SRN
DE-AR-000005685
Country
Germany
Address
77 Mergenthalerallee Eschborn
Email
ktreurope@ktreurope.de
Telephone
+49 6196 887 170
Regulatory Information
Competent Authority
DE/CA29 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:None~None, Turkey:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No