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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Otospray — 2 UDI-DI variants, MDR (Bioglan AB)

MD Atlas
Bioglan AB

Data from EUDAMED, last updated May 30, 2026

Otospray

735005784001400DR

2 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Bioglan AB

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 735005784001400DR
Device name: Otospray
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Nov 27, 2025

Manufacturer & authorised representative

Manufacturer

Name: Bioglan AB
SRN: SE-MF-000001889
Country: Sweden
Email: info@bioglan.se
Phone: +46 40 28 75 00

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KB2KHCSFYJ6CYS8YXGK3Y23R

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Otospray07350057840887
Otospray Junior07350057840900