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Organogenesis, Inc.

USA · La Jolla

✓ 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

5listed device types

Class I 0Class II 1Class III 2unclassified 2

plus 7 registration records and 12 510(k), 67 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

1active device licences

Class IV 1

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 States7 registration records, 12 510(k), 67 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ORGANOGENESIS INC.

Business registration

Legal name: Organogenesis Holdings Inc.
CIK: 0001661181
Registration status: Active
Listing status: Listed (ORGO)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11997

32001

32002

12004

12005

12007

12022

12023

FDA listed device types

Cultured Human Cell Skin Dressing 1Dressing, Wound And Burn, Interactive 1Dressing, Wound, Drug 1Wound Dressing With Animal-Derived Material(S) 1Mesh, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212579	FortiShield (Biosynthetic Wound Matrix)	2023-05-02
US	K220317	PuraPly Micronized Wound Matrix (PuraPly MZ)	2022-07-01
US	K071555	FORTAGEN ORAL MEMBRANE	2007-08-30
CA	89499	DERMAGRAFT, HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE	Class IV

Organogenesis, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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