MedDev Manufacturing Sdn Bhd

FDA Device Registration & Listing · Klang Selangor, MY · Registration 3006307105

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
3006307105
FEI Number
3006307105
Entity Name
MedDev Manufacturing Sdn Bhd
City/State/Country
Klang Selangor, MY
Establishment Address
2nd Floor, Lot 2552, Wisma Kierie, Jalan Seruling 59,, Kaw. 3, Taman Klang Jaya, Klang Selangor 41200, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SeeBreath AB (Owner Number: 10041602)
Owner / Operator Contact Address
Birger Jarlsgatan 2, Stockholm, SE-AB 11434, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CapnoDura Combi, CapnoDura Pedi

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2012-08-10

Official Correspondent

Anette Sjogren

US Agent Details

Mark Swanson Business: QRx Partners Email: mark.swanson@qrxpartners.com Phone: (833) 7797278

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009754460 SEEBREATH AB Stockholm, SE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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3016678045 Schneider ASR B.V. Rotterdam-Albrandswaard Zuid-Holland, NL
8044004 ORIDION MEDICAL 1987 LTD. JERUSALEM, IL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006307105. Last updated year: 2026. Please use registration number 3006307105 when referencing this establishment in official correspondence.
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