Kiri

Dear Jaak,

thank you very much for your quick and most competent help!

Best regards,

Angela

Best Regards,

Angela Wölfel PhD

Product- and Quality Manager

my office hours are Mo – Fr 8 – 12 a.m.

SAV Liquid Production GmbH

Hochriesstr. 2

D- 83126 Flintsbach a. Inn

phone.: +49 (0) 8034 / 909 80 26

fax: +49 (0) 8034 / 909 80 70

mail: [email protected]

www.sav-lp.de

tax no. 156/118/41644  |  UID: DE273709973  |  HRB 20423

court: Amtsgericht Traunstein

Personally liable partner is the company SAV Liquid Production GmbH mit Sitz in Flintsbach a. Inn

CEO: Herr Leonhard Schliersmaier

Our company is ISO 13485 certified

Dear Angela

Thank you for your inquiry.

Our Medical Devices and Appliances Database (EMDDB/MSA) is available here: https://msa.sm.ee/ctrl/en/Avaleht/index/.

Quick search found one medical device containing formaldehyde for sterilization purposes: https://msa.sm.ee/ctrl/en/MeditsiiniSeade/andmed/19242

Field Safety Notices (FSNs) are accessible here. We update the FSN list at the beginning of each month.

In recent years, we have had one FSN related to a medical device containing formaldehyde: Datex-Ohmeda, Inc. EVair medical air compressor Evair 03. The corrective actions are still in progress

In case of any further questions, please do not hesitate to contact us again.

Best regards

Jaak Raud

Chief Specialist

Department of Medical Devices

+372 5561 0969

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear sir or madam,

I am searching for data on medical devices containing formaldehyde on the Estonian market.

As the EUDAMED is not fully in function and I could not find a search function on the webpage Home | Government installation profile I contact you directly:

Have there been any safety notices or product recalls for medical devices containing formaldehyde for sterilization purposes on the Estonian market between 30.03.2021 and 06.11.2024?

Thank you very much.

Best Regards,

Angela Wölfel PhD

Product- and Quality Manager

my office hours are Mo – Fr 8 – 12 a.m.

SAV Liquid Production GmbH

Hochriesstr. 2

D- 83126 Flintsbach a. Inn

phone.: +49 (0) 8034 / 909 80 26

fax: +49 (0) 8034 / 909 80 70

mail: [email protected]

www.sav-lp.de

tax no. 156/118/41644  |  UID: DE273709973  |  HRB 20423

court: Amtsgericht Traunstein

Personally liable partner is the company SAV Liquid Production GmbH mit Sitz in Flintsbach a. Inn

CEO: Herr Leonhard Schliersmaier

Our company is ISO 13485 certified