SCANDINAVIAN HEALTH LTD.

FDA Device Registration & Listing · Taoyuan City, TW · Registration 9681538

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9681538
FEI Number
3004483565
Entity Name
SCANDINAVIAN HEALTH LTD.
City/State/Country
Taoyuan City, TW
Establishment Address
NO.36, Liufu Rd, Luzhu Dist, Taoyuan City 338, TW
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SCANDINAVIAN HEALTH LTD. (Owner Number: 9024700)
Owner / Operator Contact Address
NO.36, Liufu Rd, Luzhu Dist,, TAOYUAN CITY, TW-TAO 338, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NSC Injector, Pen General Hospital Class 2 880.5860 2024-03-27
KZH Introducer, Syringe Needle General Hospital Class 2 880.6920 2013-12-23

Official Correspondent

Zora Lin

US Agent Details

James Haynes Email: James.Haynes@shl-medical.com Phone: (954) 7252046

Related Public Records

Same Entity

SCANDINAVIAN HEALTH LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681538. Last updated year: 2026. Please use registration number 9681538 when referencing this establishment in official correspondence.
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