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Calamus Dual - EUDAMED Registration +D099A130000000000

Access comprehensive regulatory information for Calamus Dual 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 +D099A130000000000 and manufactured by Aseptico, Inc. in United States.

This page provides complete registration details including trade name (Dentsply), 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.

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EUDAMED Official Data
Class IIa
+D099A130000000000
Yes
Calamus Dual
Trade Name: Dentsply
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Device Description (EMDN)

ROOT CANAL FILLING DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q01010299
Trade Name
Dentsply
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
+D099A130000000000
Basic UDI
B-+D099A130000000000
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
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
Netherlands
Market Available
France:2008-01-29~2031-12-31, Italy:2008-01-29~2031-12-31, Netherlands:2008-01-29~2031-12-31, Spain:2008-01-29~2031-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No