510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Harps Europe Manufacturing

Wimpassing Niederosterreich, AT

Harps Europe Manufacturing appears in FDA device records in Wimpassing Niederosterreich, AT. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Harps Europe Manufacturing in 2025.

Clearances by year, as a table
510(k) clearance decisions for Harps Europe Manufacturing, by decision year
YearClearances
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidKGOSubstantially Equivalent

Registered establishments

FDA registered establishments for Harps Europe Manufacturing, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30074789743007478974Harps Europe ManufacturingTRIESTER BUNDESSTRASSE 26, WIMPASSING NIEDEROSTERREICH 2632 AT2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain