Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011369203

FEI Number

3011369203

Entity Name

PT NSP TECHNOLOGY BATAM

City/State/Country

Batu Ampar Riau, ID

Establishment Address

Citra Buana Centre Park Il Lot 03/Lot 01, Batu Ampar Riau 29432, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PT NSP Technology Batam (Owner Number: 10048083)

Owner / Operator Contact Address

Citra Buana Centre Park Il Lot 03/Lot 01, Batu Ampar, ID-RI 29432, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SafetiHeel, MediHeel, Novaplus SafetiCET Safety Lancet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-04-04
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-04-04
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	2015-03-04
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2014-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

PT NSP Technology Batam

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

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3010515547	PROMISEMED HANGZHOU MEDITECH CO.,LTD.	Hangzhou Zhejiang, CN
3012172036	TASSO INC	Seattle, WA, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011369203. Last updated year: 2026. Please use registration number 3011369203 when referencing this establishment in official correspondence.