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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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EarPenguin — 5 UDI-DI variants, MDR (Sibbo Medical Devices Oy)

MD Atlas
Sibbo Medical Devices Oy

Data from EUDAMED, last updated May 23, 2026

EarPenguin

6429811118EarPenguinKP

5 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: Sibbo Medical Devices Oy

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 6429811118EarPenguinKP
Device name: EarPenguin
Device model: Otoscope
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jun 6, 2023

Manufacturer & authorised representative

Manufacturer

Name: Sibbo Medical Devices Oy
SRN: FI-MF-000035896
Country: Finland
Email: info@sibbomedicaldevices.com

Variants by status

UDI-DI variants

5 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01H283YZSSC0WAPHC48SNGG9P7

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

DEP-001-H06429811118027
EP-001-H06429811118010
EPF-001-H06429811118126
APP-001-HV06429811118041
SM-001-HV06429811118003