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Aso LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000008641 FEI 1038758

Aso LLC is a medical device manufacturer based in the United States, with 520 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and Unclassified; EU Class IIa and I) and 15 FDA recalls as of 13 Nov 2026.

Devices
520
Registrations
EUDAMEDFDA
FDA recalls
152 ongoing since 2021 (3 open in total)
1 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 367
  • EUDAMED 149
  • FDA 510(k) 4

A device listed in two registries counts in both.

Device classes
  • FDA Class I 332
  • EU Class IIa 129
  • FDA Unclassified 35
  • EU Class I 20
  • FDA Class II 4
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000008641
  • FDA FEI 1038758
  • DUNS 152793493

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls
Authorised rep.
Aso Europe BVNL

What Aso LLC makes

Aso LLC manufactures antimicrobial and non-antimicrobial skin-cover adhesive strips, external nasal breathing aids, hydrophilic-gel exudate-absorbent dressings (both sterile and non-sterile), adhesive bandages, medicated first aid kits, and non-woven gauze pads. Notable examples include products like Gilbert, Mercurochrome, and Dr. Scholl’s variants, as well as the SOS first aid kit.

The company’s portfolio includes devices classified as Class I, Class II, Class IIa, N, and U, with listings in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue520

Newest first, rows 1-50 of 520

Search and filter all 520 devices
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  • Trekpleister Ref TP-1118559

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Kruidvat Ref KV-1118513

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Urgo Ref UR-606369

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • M-Plast Ref BEV-9382

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • ZzzQuil Ref ZQ-80826439

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Clarel Ad Bene Ref CLA-FOT014

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Livsane Ref LIV-1100B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Livsane Ref LIV-1100A

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Livsane Ref LIV-11438

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-4000186 / SCH-4000186 / 76-7006678

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • First-Plast Ref GT-FP-3366

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • SilaVit Ref SIL-200002788

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Dr. Seuss 017276240986

    Listed Registry: GUDID Class:I

  • Care Science 017276241280

    Listed Registry: GUDID Class:I

  • Care Science 017276241310

    Listed Registry: GUDID Class:I

  • Bluey First Aid Kit 017276241334

    Listed Registry: GUDID Class:—

  • Rapid Seal 017276241709

    Listed Registry: GUDID Class:—

  • ZzzQuil Ref ZQ-80826438

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Livsane Ref LIV-3530

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Urgo Ref UR-606116

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Matopat Comfort Plus Mix Ref TZMO-MA-167-GLMM-094

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ica Ref ICA170802

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Holthaus Medical Ref HOL-3003 / 18 420

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-9038277 / 76-9038277

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ica Ref ICA170800

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-4000185 / SWC-4000185 / 76-7006691

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Mercurochrome Ref JUV-050895 / F050895B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Gilbert Ref GIL-251573

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Mercurochrome Ref JUV-050916 / F050916F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Hema Ref HE-0818584

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Hema Ref HE-0818583

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-3206621 / SWC-3206621 / 76-7006708

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-3197564 / SWC-3197564 / 76-7006673

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-4000174 / SWC-4000174 / 76-7006687

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-3197573 / SWC-3197573 / 76-7006711

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-3197557 / SWC-3197557 / 76-7006688

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-4000199 / SWC-4000199 / 76-7006690

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-3197558 / SWC-3197558 / 76-7006669

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Sos Ref SOS-054026

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's Ref SCH-3197679 / SWC-3197679 / 76-7006667

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ica Ref ICA170801

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Heka Ref VH-OT0174

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Medipeed Sportdoc Ref UN-SD540003

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIa

  • Wells Ref WEL-2318502

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ProFoot Ref PRO-1200

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • matas STRIBER Ref MAT-CP1100 / CP-1100

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Urgo Ref UR-604646

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dr. Scholl's PHARMA Ref SWC-9038537 / 76-7006709

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Homann Ref HO-1000

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIa

  • Medolin Ref MLN-10001

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Rows 1-50 of 520

Showing 1-50 of 520

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000008641
FDA FEI number
1038758
DUNS number
152793493
EUDAMED status
Active
EUDAMED registered name
ASO LLC
EUDAMED abbreviated name
ASO
Registered address
300, Sarasota Center Blvd., 34240, Sarasota, United States
Phone
+31 24 343 54 80
PRRC contact
Federico Juliao(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 20 Jul 2030

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 792557 Active

    Quality assurance EU MDR

    Issued
    21 Jul 2025
    Expires
    20 Jul 2030

FDA recalls15

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 15 recalls initiated by Aso LLC, the earliest on 2013-07-26 and the most recent on 2023-03-23. By recorded status: 3 ongoing and 12 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 2
  • 2023 1
  • 2024 0
  • 2025 0
  • 2026 0

11 initiated before 2017

Showing the 10 most recent of 15 recalls.

  • 2023

    • 23 Mar 2023 Z-1499-2023 Class II Ongoing The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling. Distribution: US Nationwide Distribution: IL. FL, CA, CT, OH, TX, IL, SC, and WI

  • 2022

    • 22 Jun 2022 Z-1517-2022 Class II Ongoing The product falls apart during handling after removal from its primary packaging. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI SC, TN, TX,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI SC, TN, TX, and VA. The country of Canada.
    • 2 Mar 2022 Z-1031-2022 Class II Terminated Kits contained recalled acetaminophen. Distribution: US Nationwide distribution.

  • 2018

    • 16 Oct 2018 Z-0525-2019 Class II Open since 2018 Potential that gauze pads may not be fully sterilized Distribution: Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.

  • 2015

    • 10 Jun 2015 Z-2460-2015 Class II Terminated Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label. Distribution: US Distribution to Rhode Island only

  • 2013

    • 21 Aug 2013 Z-0004-2014 Class II Terminated No antibacterial bandages were packed in boxes labeled as antibacterial. Distribution: Distributed in the states of ID, WI, IN, and NE.
    • 26 Jul 2013 Z-1888-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
    • 26 Jul 2013 Z-1889-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
    • 26 Jul 2013 Z-1890-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
    • 26 Jul 2013 Z-1891-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
Show all 15 recalls

  • 2013

    • 26 Jul 2013 Z-1892-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
    • 26 Jul 2013 Z-1893-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
    • 26 Jul 2013 Z-1894-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
    • 26 Jul 2013 Z-1895-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
    • 26 Jul 2013 Z-1896-2013 Class II Terminated This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Distribution: Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.

Frequently asked questions

How many devices does Aso LLC have in the registry?

The registry currently lists 520 devices for Aso LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Aso LLC's devices?

Among its 50 most recently registered devices, Aso LLC has devices listed in EUDAMED (45 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Aso LLC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Aso LLC's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

Are there FDA recall records for Aso LLC?

FDA recall records list 15 recalls initiated by Aso LLC, the most recent initiated on 23 Mar 2023. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Aso LLC?

EUDAMED lists 1 certificate for Aso LLC (quality assurance) under MDR. 1 is recorded with the status issued. The most recent was issued on 21 Jul 2025.

What are the newest devices from Aso LLC in the registry?

The most recently registered devices listed for Aso LLC include Trekpleister, Kruidvat, URGO and M-Plast.

Generated automatically from registry data and not verified by a human reviewer.