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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

002004 — Class I MDR by PANACEA, s.r.o.

MD Atlas
PANACEA, s.r.o.

EUDAMED last updated this device on Feb 21, 2025

002004

8588002484resus.rusko3Q

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PANACEA, s.r.o.
UDI-DI code: 08588002484872
Reference / catalog number: 002004

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View device family (Basic UDI)

Manufacturer information

Organization name: PANACEA, s.r.o.
SRN: SK-MF-000003682
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Slovakia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08588002484872
Basic UDI-DI: 8588002484resus.rusko3Q
Reference / catalog number: 002004
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: Pro dýchaní z úst do úst, nesterilní. Vyčistit dutinu ústnu, zabezpečit průchodnost dýchacích cest (záklon hlavy, předsunutí dolní čelisti), mezi čelistě postiženého vložit náustek roušky, zahájit resuscitaci dle zásad poskytování první pomoci.
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)08588002484872

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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.

R9001RESPIRATORY MOUTHPIECES

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.