Home›USA›Aspen Medical Products

Aspen Medical Products

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 7 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

0UDI-DI device records

USUnited StatesFDA openFDA

12listed device types

Class I 12Class II 0Class III 0

plus 12 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 7

BRBrazilANVISA

2registered devices

Class I 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

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.

European Union7,926 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States12 registration records, 1 510(k), 0 PMA, 14 excluded

United Kingdom7 confirmed, 2 excluded

Brazil2 confirmed, 3 excluded

Saudi Arabia1 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: ASPEN MEDICAL PRODUCTS, LLC · ASPEN MEDICAL PRODUCTS · Aspen Medical Products LLC

Regulatory identity

UK responsible person: Promedics Orthopaedics Limited

FDA 510(k) clearances by year

11992 · K914300

FDA listed device types

showing 8 of 12

Orthosis, Limb Brace 1Joint, Knee, External Brace 1Orthosis, Lumbar 1Shoe, Cast 1Sling, Arm 1Orthosis, Cervical 1Orthosis, Thoracic 1Orthosis, Foot Drop 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	36206	ASPEN M2 AFO, ANTERIOR LEFT, LARGE	Class I
UK	45129	ASPEN COLLAR BACK PANEL REPLACEMENT PAD, SMALL	Class I
UK	41065	ASPEN SUSPENSION WRAP	Class I
US	K914300	PHOENIX 5 URODYNAMICS SYSTEM	1992-06-02
BR	80117580120	ortese para coluna vertebral	Class I
BR	80117580118	COLAR CERVICAL ASPEN	Class I
SA	ME0000012680SFDAA00001	Vista Collar	—

Aspen Medical Products

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies