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BIOMEDIX-INC

Last updated May 25, 2026

What BIOMEDIX-INC makes

BIOMEDIX-INC manufactures intravenous administration tubing extension sets, including models such as the Biomedix B95 SELEC-3+NIS IV ADM. SET, Biomedix B12 SELEC-3+NIS IV ADM. SET, and Biomedix B10 SELEC-3 IV ADM. SET.

The company's products are Class II devices listed in the FDA 510(k) and FDA UDI registries, and the company is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What type of medical devices does Biomedix-Inc manufacture?

Biomedix-Inc manufactures intravenous administration tubing extension sets, as indicated by the device categories and example devices provided, which are all variations of IV administration sets with different configurations such as SELEC-3+NIS, SELEC-3+SC, and SELEC-3+LAS.

Where is Biomedix-Inc based?

Biomedix-Inc is based in the United States, as explicitly stated in the COUNTRY field of the device data, which specifies US as the country of origin for the manufacturer.

In which regulatory registries are Biomedix-Inc's devices listed?

Biomedix-Inc's devices are listed in the FDA 510(k) and FDA UDI registries, as shown in the LISTED IN field, which identifies these two specific regulatory databases where the company's products are registered.

How are Biomedix-Inc's devices classified under regulatory frameworks?

Biomedix-Inc's devices are classified as Class II medical devices, as stated in the DEVICE CLASSES field, which indicates the risk-based classification level assigned to their intravenous administration tubing extension sets under applicable regulatory standards.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 798045530

Catalogue (27)

Device	Model / Reference	Registries	Class	Status
Biomedix B95 SELEC-3+NIS IV ADM. SET	B95-102	FDA UDI	Class II	Active
Biomedix B12 SELEC-3+NIS IV ADM. SET	B12-102	FDA UDI	Class II	Active
Biomedix B10 SELEC-3 IV ADM. SET	B10-102	FDA UDI	Class II	Active
Biomedix B15 SELEC-3+SC+NIS IV ADM. SET	B15-102	FDA UDI	Class II	Active
Biomedix B62 SELEC-3+NIS+LAS IV ADM. SET	B62-102	FDA UDI	Class II	Active
Biomedix B36 SELEC-3+LAS IV ADM. SET	B36-102	FDA UDI	Class II	Active
Biomedix B39 SELEC-3+SC+LAS IV ADM. SET	B39-102	FDA UDI	Class II	Active
Biomedix B11 SELEC-3+SC IV ADM. SET	B11-102	FDA UDI	Class II	Active
Biomedix B37 SELEC-3+NIS+LAS IV ADM. SET	B37-102	FDA UDI	Class II	Active
Biomedix B76 SELEC-3+LAS IV ADM. SET	B76-102	FDA UDI	Class II	Active
Biomedix B30 SELEC-3+NIS+LAS IV ADM. SET	B30-102	FDA UDI	Class II	Active
Biomedix B74 SELEC-3+NIS+LAS IV ADM. SET	B74-102	FDA UDI	Class II	Active
Biomedix B31 SELEC-3+NIS+LAS IV ADM. SET	B31-102	FDA UDI	Class II	Active
Biomedix B72 SELEC-3+NIS+LAS IV ADM. SET	B72-102	FDA UDI	Class II	Active
Biomedix B38 SELEC-3+NIS+LAS IV ADM. SET	B38-102	FDA UDI	Class II	Active
Biomedix B32 SELEC-3+NIS+LAS IV ADM. SET	B32-102	FDA UDI	Class II	Active
Endogrip	K926498	FDA 510(k)	Class II	Active
Q.steps Biometer G Blood Glucose Monitoring System	K033627	FDA 510(k)	Class II	Active
Q.steps Biometer G/C Dual Monitoring System	K050182	FDA 510(k)	Class II	Active
Flostat Vascular Report Generator (vrg)	K973857	FDA 510(k)	Class II	Active
Padnet 2.0	K122281	FDA 510(k)	Class II	Active
Biomedix I.v. Extension Line W/ Stopcock Model B50-102/B51-102	K961928	FDA 510(k)	Class II	Active
Biomedix Padnet Lab	K042616	FDA 510(k)	Class II	Active
Selec-3	K925645	FDA 510(k)	Class II	Active
Padnet+	K073146	FDA 510(k)	Class II	Active
Flostat Vascular Lab	K973644	FDA 510(k)	Class II	Active
Selec-3 I.v.administration Set	K142097	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There is 1 recall record for Biomedix-Inc, initiated on August 14, 2014, with a status of terminated. The reason given for the recall was that a customer contacted Biomedix regarding a complaint and returned a failed set along with 86 units of unopened stock, out of 96 units originally shipped. Biomedix conducted an investigation and found insufficient application of glue, leading to the recall being initiated due to the rate of failure.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Aug 14, 2014	Z-0023-2015	—	terminated	Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.