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Locking Bolt Dia. 4.9mm Self Tapping - Titanium Length 34mm - EUDAMED Registration 08907536038649

Access comprehensive regulatory information for Locking Bolt Dia. 4.9mm Self Tapping - Titanium Length 34mm in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 08907536038649 and manufactured by SIORA SURGICALS PVT. LTD. in India.

This page provides complete registration details including trade name (SIORA), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24), 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 IIb
08907536038649
No
Locking Bolt Dia. 4.9mm Self Tapping - Titanium Length 34mm
Trade Name: SIORA
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Device Description (EMDN)

INTRAMEDULLARY NAILS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09120201
Trade Name
SIORA
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08907536038649
Basic UDI
B-08907536038649
Version Date
March 05, 2024
Manufacturer Last Update
June 20, 2023
Active Status
No
Manufacturer
Manufacturer Name
SIORA SURGICALS PVT. LTD.
Country
India
Country Type
NON_EU
Address
1792, HSIIDC Industrial Estate, Rai, Sonepat
Email
rupit@siora.net
Authorized Representative
SRN
DE-AR-000004974
Country
Germany
Address
97 Alsstr. Mรถnchengladbach
Email
joe@europecert.eu
Telephone
+49 2161 990 88 31
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Denmark
Market Available
Denmark:2024-02-07~None
Device Characteristics
Human Tissues
No
Animal Tissues
No