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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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Organization name
UDI-DI code
Reference / catalog number

EPF-001-H — Class I MDR by Sibbo Medical Devices Oy

MD Atlas
Sibbo Medical Devices Oy

EUDAMED last updated this device on Feb 24, 2025

EPF-001-H

6429811118EarPenguinKP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sibbo Medical Devices Oy
UDI-DI code: 06429811118126
Reference / catalog number: EPF-001-H

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Manufacturer information

Organization name: Sibbo Medical Devices Oy
SRN: FI-MF-000035896
Manufacturer status: Active

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DEP-001-H6429811118EarPenguinKPOn the market EP-001-H6429811118EarPenguinKPOn the market SC-001-H6429811118CyclopsTBOn the market SL-001-H6429811118LoupeQQOn the market APP-001-HV6429811118EarPenguinKPOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 06429811118126
Basic UDI-DI: 6429811118EarPenguinKP
Reference / catalog number: EPF-001-H
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Simplified Digital EarPenguin model
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12021007MIDDLE EAR OTOSCOPES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification