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Stack Splint - EUDAMED Registration 06976009954382

Access comprehensive regulatory information for Stack Splint in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06976009954382 and manufactured by Xiamen LongStar Medical Equipment Co., Ltd in China.

This page provides complete registration details including trade name (Stack Splint), 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 I
06976009954382
No
Stack Splint
Trade Name: Stack Splint
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Device Description (EMDN)

MEDICAL SUPPORT EQUIPMENT - ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V0880
Trade Name
Stack Splint
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06976009954382
Basic UDI
6976009954382DS
Version Date
March 26, 2023
Manufacturer Last Update
March 20, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Unit 101, No. 23 Wulv Village, DaDianLi, XinMin Town, Tong'An District Xiamen City, Fujian Province
Email
Anna@fg-brace.com
Authorized Representative
SRN
NL-AR-000001490
Country
Netherlands
Address
701 Joop Geesinkweg Amsterdam-Duivendrech
Email
ce-tech@humiss.com
Telephone
+31 (0)20 369 8116
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No