HARPS Investment Asia Pte. Ltd.
Active in EUDAMEDSingaporefrom SRN EUDAMED FDA SRN SG-MF-000001645 FEI 3010605427
- Devices
- 369
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
- Authorised rep.
- HARPS Europe GmbHAT
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.
Catalogue
Search and filter all 369 devicesShowing 1-50 of 369
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
- Website
- www.sempermed.com
- linkedin.com/company/harpsglobal
- [email protected]
- PRRC contact
- Birgit Sebauer
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 6 Aug 2028
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
Quality management system EU MDR
- Issued
- 18 Sep 2026
- Expires
- 6 Aug 2028
- Reason
- Mnf ar change
Frequently asked questions
How many devices does HARPS Investment Asia Pte. Ltd. have in the registry?
The registry currently lists 369 devices for HARPS Investment Asia Pte. Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list HARPS Investment Asia Pte. Ltd.'s devices?
Among its 50 most recently registered devices, HARPS Investment Asia Pte. Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do HARPS Investment Asia Pte. Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for HARPS Investment Asia Pte. Ltd.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for HARPS Investment Asia Pte. Ltd.?
EUDAMED lists 2 certificates for HARPS Investment Asia Pte. Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 18 Sep 2026.
What are the newest devices from HARPS Investment Asia Pte. Ltd. in the registry?
The most recently registered devices listed for HARPS Investment Asia Pte. Ltd. include sempermed green X-free, semperguard skySense, sempermed latex edition IC and semperguard sapphire (200).