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Locking Plate - EUDAMED Registration D-SDP-01/09SP4

Access comprehensive regulatory information for Locking Plate 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 D-SDP-01/09SP4 and manufactured by Chongqing FWS Medical Device Co.,Ltd in China.

This page provides complete registration details including trade name (SDP-01 Femoral Dry Locking Plate (9 hole) (sterile)), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
D-SDP-01/09SP4
No
Locking Plate
Trade Name: SDP-01 Femoral Dry Locking Plate (9 hole) (sterile)
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Device Description (EMDN)

BONE FIXATION PLATES - OTHER

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09120599
Trade Name
SDP-01 Femoral Dry Locking Plate (9 hole) (sterile)
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-SDP-01/09SP4
Basic UDI
B-SDP-01/09SP4
Version Date
December 24, 2021
Manufacturer Last Update
July 01, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Buildings 18 NO.399 Jingdongfang Avenue, Beibei District, Chongqing
Email
Deng-Lu@fws-china.com
Authorized Representative
SRN
NL-AR-000002066
Country
Netherlands
Address
36 Zonnehof Nootdorp
Email
office@kingsmead-service.com
Telephone
+31(0) 64 6571 005
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Netherlands
Market Available
Netherlands:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No