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HARPS Investment Asia Pte. Ltd.

Active in EUDAMED

Singaporefrom SRN EUDAMED FDA SRN SG-MF-000001645 FEI 3010605427

Devices
369
Registrations
EUDAMEDFDA
FDA recalls
0

What HARPS Investment Asia Pte. Ltd. makes

HARPS Investment Asia Pte. Ltd. manufactures medical gloves, including nitrile and latex powder-free options, as well as sterile surgical gloves. Their product lines feature various models such as semperguard, sempermed, ORBIS, Vasco, and peppler, designed for different medical applications.

The company's devices are classified as Class I and Class IIa and are listed in the EUDAMED regulatory registry. HARPS Investment Asia Pte. Ltd. is based in Singapore.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue369

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Company details

EUDAMED SRN
SG-MF-000001645
FDA FEI number
3010605427
EU VAT number
201221964N
EUDAMED status
Active
EUDAMED registered name
HARPS Investment Asia Pte. Ltd.
Registered address
1, Harbourfront Avenue, 098632, Singapore, Singapore
PRRC contact
Birgit Sebauer(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 6 Aug 2028

EUDAMED certificates (2)

DNV Product Assurance AS 2460 1 certificate

  • C621238 Active

    Quality management system EU MDR

    Issued
    12 Mar 2026
    Expires
    11 Mar 2031

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G11 088308 0023 Active Amended

    Quality management system EU MDR

    Issued
    18 Sep 2026
    Expires
    6 Aug 2028
    Reason
    Mnf ar change