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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

191 — Class I MDR by TERRAPROMO d.o.o. za…

MD Atlas
TERRAPROMO d.o.o. za trgovinu i usluge

EUDAMED last updated this device on Mar 29, 2026

191

38560311OxygenOptimalNP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TERRAPROMO d.o.o. za trgovinu i usluge
UDI-DI code: 03856031101226
Reference / catalog number: 191

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Manufacturer information

Organization name: TERRAPROMO d.o.o. za trgovinu i usluge
SRN: HR-MF-000041636
Manufacturer status: Active

Related devices

190238560311OxygenOptimalNPOn the market 190138560311OxygenOptimalNPOn the market 190338560311OxygenOptimalNPOn the market 190438560311OxygenOptimalNPOn the market 191738560311OxygenOptimalNPOn 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 Croatia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03856031101226
Basic UDI-DI: 38560311OxygenOptimalNP
Reference / catalog number: 191
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: Medical device intended to improve local microcirculation, promote thermoregulation, and alleviate symptoms of peripheral circulation issues through infrared (IR) energy reflection.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Large, EU size 39-41

EMDN nomenclature code(s)

Y090699DEVICES FOR BODY PROTECTION - OTHER

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

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