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Spectrum Plastics Group

USA · Saint Louis Park

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

16listed device types

Class I 4Class II 10Class III 1unclassified 1

plus 20 registration records and 2 510(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

0active device licences

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 States20 registration records, 2 510(k), 0 PMA, 43 excluded

Brazil0 confirmed, 7 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: Spectrum Plastics Group · APEX RESOURCE TECHNOLOGIES, INC., PPC INDUSTRIES, A SPECTRUM PLASTICS GROUP CO.

FDA 510(k) clearances by year

12018 · K180708

12023 · K232046

FDA listed device types

showing 8 of 16

Fastener, Fixation, Biodegradable, Soft Tissue 1Staple, Fixation, Bone 1Flowmeter, Blood, Cardiovascular 1Pin, Fixation, Smooth 1Plate, Fixation, Bone 1Polymer, Ear, Nose And Throat, Synthetic, Absorbable 1Screw, Fixation, Bone 1Device, Anastomotic, Microvascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232046	Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection	2023-10-06
US	K180708	Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit	2018-10-18

Spectrum Plastics Group

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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