SPECIALPLAST WENSBO AB

FDA Device Registration & Listing · Gislaved Jonkoping, SE · Registration 3013484413

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013484413
FEI Number
3013484413
Entity Name
SPECIALPLAST WENSBO AB
City/State/Country
Gislaved Jonkoping, SE
Establishment Address
Baldersvaegen, Gislaved Jonkoping 33235, SE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Specialplast Wensbo AB (Owner Number: 10090990)
Owner / Operator Contact Address
Baldersvaegen, Gislaved, SE-F 33235, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Laerdal Face Shield

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2024-06-12
NZU Collector, Urine, Powered, Non Indwelling Catheter Gastroenterology, Urology Class 1 876.5250 2026-03-26

Official Correspondent

No official correspondent registered.

US Agent Details

Mittal Suthar Business: Target Health Email: msuthar@targethealth.com Phone: (212) 6812105

Related Public Records

Same Entity

Specialplast Wensbo AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2010 Unomedical 2
Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010 Unomedical 2
Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010 Unomedical 2
Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013484413. Last updated year: 2026. Please use registration number 3013484413 when referencing this establishment in official correspondence.
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