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Aspen Surgical Corp.

USA · Caledonia MI · www.aspensurgical.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN US-MF-000008255

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 11 overseas markets. EU UDI-DI records ≥100, the first 300 verified individually. 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

≥100UDI-DI device records

Class I 100

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

655listed device types

Class I 601Class II 53Class III 0unclassified 1

plus 770 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

398registered device records

Class I 290Class IIa 56Class IIb 42System or Procedure Pack 10

BRBrazilANVISA

44registered devices

Class I 26Class II 18

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

SASaudi ArabiaSFDA

17registered imported devices

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

CACanadaMDALL

11active device licences

Class II 11

105 including historic records

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

157active ARTG entries

Class I 77IIa 24IIb 15Class Is (sterile) 41

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

13registrations

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, 0 excluded, 100 confirmed. Large result set — only the first 300 verified

United States770 registration records, 2 510(k), 0 PMA, 12 excluded

United Kingdom398 confirmed, 2 excluded

Brazil44 confirmed, 1 excluded

Saudi Arabia17 confirmed, 1 excluded

Canada11 confirmed, 1 excluded

Manufacturer names merged into this page: ASPEN SURGICAL PRODUCTS, INC. · Aspen Surgical Puerto Rico Corp. · Aspen Surgical Products, Inc. · ASPEN SURGICAL PRODUCTS INC · ASPEN SURGICAL · ASPEN SURGICAL PUERTO RICO CORP.

Regulatory identity

EU manufacturer SRN: US-MF-000008255
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

Business registration

Legal name: Aspen Surgical Products, Inc.
LEI: 2549000YJPB7BI758N38
Registration status: Active
Legal form: Corporation (For-Profit) (Corp.)
Incorporated: 1999-02-03
Registered address: C/O The Corporation Company, Playmouth, 48170
Registration authority: Corporations Division (Department of Licensing and Regulatory Affairs), no. 800076014
Registry record updated: 2026-02-09

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

FDA 510(k) clearances by year

12002 · K020304

12003 · K030339

FDA listed device types

showing 8 of 655

Pad, Eye 1Syringe, Restorative And Impression Material 1Knife, Nasal 1Cannula, Ventricular 1Instrument, Contouring, Matrix, Operative 1Drill, Dental, Intraoral 1Strip, Adhesive, Closure, Skin 1Prealbumin, Fitc, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00887482122679	Symmetry®	Class I
EU	00887482042564	Symmetry®	Class I
EU	00887482122662	Symmetry®	Class I
EU	00887482122655	Symmetry®	Class I
UK	47862	Reusable Surgical Instruments	Class I
UK	47862	Reusable Surgical Instruments	Class I
UK	10025	Reusable Surgical Instruments	Class I
US	K030339	CAUTERY TIP CLEANER, MODEL-TC-100	2003-03-07
US	K020304	DISPOSABLE LIGHT HANDLE AND ADAPTOR	2002-02-14
BR	10315990081	CONJUNTO S-VAC BULB EVACUATOR	Class II
BR	10315990082	CONJUNTO SABER® PVC BULB EVACUATOR	Class II
BR	10315990083	CONJUNTO S-VAC BULB EVACUATOR FLUTED	Class II
SA	ME0000008518SFDAA00002	Color Track Instrument Identification Sheet Tape	—
SA	ME0000007350SFDAA00007	Oxboro® Instrument Tip Protectors	—
CA	21849	VESSEL LOOPS	Class II
CA	60871	OPHTHALMIC - CANNULAE - STAINLESS STEEL AND NYLON	Class II
CA	60872	OPHTHALMIC CANNULAE - STAINLESS STEEL, NYLON AND BRASS	Class II