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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

Pulse300 Dual7 — Class I MDR by Nuovo Therapy s.r.o.

MD Atlas
Nuovo Therapy s.r.o.

EUDAMED last updated this device on Mar 9, 2026

Pulse300 Dual7

85820000821LEDUC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Nuovo Therapy s.r.o.
UDI-DI code: 08582000082146
Reference / catalog number: Pulse300 Dual7

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View device family (Basic UDI)

Manufacturer information

Organization name: Nuovo Therapy s.r.o.
SRN: SK-MF-000051689
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Do not look directly into the light source. Eye protection should be used when treating areas close to the eyes. Do not use on patients with known photosensitivity or when taking photosensitizing medications. Use only as described in the instructions for use.

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Market distribution

Primary placement in Czechia; available across 1 country total.

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

Device identification

Trade name: Pulse300 Dual7
UDI-DI code: 08582000082146
Basic UDI-DI: 85820000821LEDUC
Reference / catalog number: Pulse300 Dual7
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08582000082146

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z120614INFRARED ULTRAVIOLET RAY LAMPS

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

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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.