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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

1915 — 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

1915

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: 03856031155625
Reference / catalog number: 1915

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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

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: 03856031155625
Basic UDI-DI: 38560311OxygenOptimalNP
Reference / catalog number: 1915
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: Extra extra large, EU size: 45-47

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.