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Genzyme Surgical Product (Genzyme Biosurgery)

USA · Fall River

✓ 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

13510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 13 510(k), 15 PMA

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

6active device licences

Class III 5Class IV 1

7 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 States0 registration records, 13 510(k), 15 PMA, 10 excluded

Brazil0 confirmed, 1 excluded

Canada6 confirmed, 2 excluded

Manufacturer names merged into this page: GENZYME BIOSURGERY, A DIVISION OF GENZYME CORPORATION

Same-named companies — This database also contains companies with near-identical names: Genzyme Biosurgery, GENZYME BIOSURGERY, A DIVISION OF GENZYME CORPORATION. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K031554	S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM	2003-07-25
US	K030212	MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE	2003-03-27
US	K022989	RADLITE TISSUE RETRACTOR SYSTEM	2002-11-25
CA	9717	SEPRACOAT COATING SOLUTION	Class III
CA	20687	SEPRAMESH BIOSURGICAL COMPOSITE	Class III
CA	20693	CV SEPRAFILM CARDIOVASCULAR ADHESION BARRIER	Class IV

Genzyme Surgical Product (Genzyme Biosurgery)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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