Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018805824

FEI Number

3018805824

Entity Name

BIOTRONIK APM PTE. LTD

City/State/Country

Singapore South East, SG

Establishment Address

1 Kaki Bukit View #03-24/34 Techview, Lobby C, Singapore South East 415941, SG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIOTRONIK AG (Owner Number: 10024585)

Owner / Operator Contact Address

Ackerstrasse 6, Buelach, CH-ZH CH-8180, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orsiro Orsiro Mission

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2019-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Divya Raman Business: Teleflex, Inc Email: FDA.US.Agent@teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

BIOTRONIK AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043892	BIOTRONIK AG	BULACH Zurich, CH
3011574793	CORTRONIK GmbH	Rostock-Warnemuende Mecklenburg-Western Pomerania, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018805824. Last updated year: 2026. Please use registration number 3018805824 when referencing this establishment in official correspondence.