Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030905

FEI Number

3002622835

Entity Name

J.H.ORSING AB

City/State/Country

Helsingborg Skane, SE

Establishment Address

TORBORNAVAGEN 26, Helsingborg Skane SE-25016, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

J.H.ORSING AB (Owner Number: 8030905)

Owner / Operator Contact Address

P.O. BOX 16077 TORBORNAVAGEN, 26, RAA, SE-NOTA S-25016, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hygoformic U Soft adapter Bio Hygoformic Bio Hygoformic L Soft adapter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	1992-11-25

Official Correspondent

Ewa-Lotte Pedersen

US Agent Details

Yasily Ogando Roa Business: Parkell Inc Email: yogando@parkell.com Phone: (631) 3891560

Related Public Records

Same Entity

J.H.ORSING AB

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

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1123010	TRINITY STERILE, INC.	SALISBURY, MD, US
3016789258	EG-MEDACYS DEVICES(SHENZHEN)CO.,LTD	SHENZHEN Guangdong, CN
3014146451	HUBEI V-MEDICAL PRODUCTS CO., LTD.	Xiantao Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030905. Last updated year: 2026. Please use registration number 8030905 when referencing this establishment in official correspondence.