BLUEPOINT MEDICAL GMBH & CO. KG

FDA Device Registration & Listing · Selmsdorf Mecklenburg-Western Pomerania, DE · Registration 3012834717

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
3012834717
FEI Number
3012834717
Entity Name
BLUEPOINT MEDICAL GMBH & CO. KG
City/State/Country
Selmsdorf Mecklenburg-Western Pomerania, DE
Establishment Address
An der Trave 15, Selmsdorf Mecklenburg-Western Pomerania 23923, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Bluepoint Medical GmbH & Co. KG (Owner Number: 10054095)
Owner / Operator Contact Address
An der Trave 15, Selmsdorf, DE-MV 23923, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190824
PMA Number
N/A

All Registered Proprietary Names

NELLCOR FLEXMAX-P-HC Flexible SpO2 Sensor, Reusable, Homecare, Small NELLCOR FLEXMAX-P Flexible SpO2 Sensor, Reusable, Small NELLCOR FLEXMAX Flexible SpO2 Sensor, Reusable NELLCOR FLEXMAX-HC Flexible SpO2 Sensor, Reusable, Homecare 5514182 Gas exhaust line, 1 m/3.3 ft 5514183 Gas exhaust line, 0.18 m/7 in 5514184 Gas exhaust line, 2 m/6.6 ft Airway Gas Sampling Products

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2017-02-09
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2026-02-03
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-11-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-01-30
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2020-01-30

Official Correspondent

Stephen Gorski

US Agent Details

Stephen Gorski Business: Imagenix, Inc. Email: stephengorski@me.com Phone: (414) 7374596

Related Public Records

Same Entity

Bluepoint Medical GmbH & Co. KG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012834717. Last updated year: 2026. Please use registration number 3012834717 when referencing this establishment in official correspondence.
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