HomeUSABusse Hospital Disposables, Inc.

Busse Hospital Disposables, Inc.

USA · Hauppauge
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
78listed device types
Class I 39Class II 39Class III 0
plus 92 registration records and 37 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
32active device licences
Class II 32
52 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States92 registration records, 37 510(k), 0 PMA, 1 excluded
Canada32 confirmed, 0 excluded
Manufacturer names merged into this page: BUSSE HOSPITAL DISPOSABLES
Same-named companies — This database also contains companies with near-identical names: Hospital Disposables, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Hauppauge

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11984
21986
11987
31988
21990
21994
51995
11996
12001
12002
12003
12004
32006
22007
32008
22009
22010
12011
12012
12015

FDA listed device types

showing 8 of 78
Cap, Surgical 1Pad, Menstrual, Unscented 1Forceps 1Container, Specimen, Sterile 1Scissors, Medical, Disposable 1Label Or Tag, Sterile 1Needle, Aspiration And Injection, Disposable 1Punch, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK141285BUSSE EXTENSION SET2015-02-19
USK120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE2012-06-26
USK110883J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA2011-06-08
CA7486INCISION & DRAINAGE INSTRUMENT PACKClass II
CA7497LAMINARIA CERVICAL DILATORClass II
CA7501SIGMOIDOSCOPE SUCTION INSTRUMENTClass II

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