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EUDAMED registration 10817417021200Yes

IMPLANT SURGERY SYSTEM ENDO

Aseptico, Inc.Class IIaEU EUDAMEDTrade name: Aseptico
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Q010399
Trade name
Aseptico
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
10817417021200
Basic UDI
B-10817417021200
Version date
March 06, 2025
Manufacturer last update
October 05, 2021
Active status
Yes
Manufacturer
Manufacturer name
Aseptico, Inc.
Country
United States
Country type
NON_EU
Address
8333 216th St SE Woodinville
Email
regulatory@aseptico.com
Authorized representative
Name
Advena Limited
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory information
Competent authority
Malta Medicines Authority
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Germany
Market available
Germany:2025-03-29~2035-05-31, Italy:2025-03-29~2035-05-31, Spain:2025-03-29~2035-05-31
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SURGICAL DENTAL DEVICES - OTHER

About this record

Access comprehensive regulatory information for IMPLANT SURGERY SYSTEM ENDO in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 10817417021200 and manufactured by Aseptico, Inc. in United States.

This page provides complete registration details including trade name (Aseptico), manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), 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.