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Wellspect HealthCare (Division of DENTSPLY IH AB), Molndal, Sweden – FDA Inspections

Inspection records and compliance data for Wellspect HealthCare (Division of DENTSPLY IH AB) in Molndal. 2 FDA inspections on record, 1 Form 483, last inspected September 13, 2018.

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Company Profile

This profile covers Wellspect HealthCare (Division of DENTSPLY IH AB) based in Molndal, Sweden.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
0
NAI
1
Unclassified
1
Form 483s
1
Warning letters
0

First inspected August 13, 2015. Last inspected September 13, 2018.

FDA inspections (2)

DateResultFDA center(s)Insp. #
September 13, 2018Not classifiedMedical Devices & Rad Health1131709
August 13, 2015NAIMedical Devices & Rad Health · Compliance: Devices941866
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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St. Jude Medical Systems AB
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Company Information

Name

Wellspect HealthCare (Division of DENTSPLY IH AB)

FEI Number

3009632672

Address

Amino Gatan 1, Molndal, Sweden

Country

Sweden

ID: 2e998d8a-49d4-42e0-b3fc-325084cc7c0c

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