Regulatory & Compliance

Helmer Scientific is a FDA GMP and ISO13485 compliant manufacturer of medical devices.

Certifications

Certificate of Registration

Certificate of Regulatory Compliance

Certificate of Regulatory Compliance

Refrigerators & Freezers

FDA - Certificate to Foreign Government

Platelet Agitators & Incubators

FDA - Certificate to Foreign Government

Cell Washer UltraCW^®II

FDA - Certificate to Foreign Government

FDA - Certificate to Foreign Government

Platelet Incubator

EC Declaration of Conformity

Platelet Agitator

EC Declaration of Conformity

EC Declaration of Conformity

Refrigerator and Freezer

EC Declaration of Conformity

SDS

SDS

SDS

Propylene Glycol

SDS

Glycerin (Glycerol)

SDS

Waterbath Conditioning Liquid (5-34-002)

SDS

Battery Test Summaries

9V Lithium - Energizer

120399

9V Lithium - UltraLife

120399

Coin Lithium - Panasonic

121040

Coin Lithium - CR1220

i.Center^® Plus Display – Lithium Battery

Lithium - CR2032W

Lithium Metal Battery Cell

Lithium - CR2032X

Lithium Metal Battery Cell