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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

CME000228 — Class I MDR by Elvika

MD Atlas
Elvika

EUDAMED last updated this device on Nov 22, 2024

CME000228

4750879CMYHT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Elvika
UDI-DI code: 04752107000228
Reference / catalog number: CME000228

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View device family (Basic UDI)

Manufacturer information

Organization name: Elvika
SRN: LV-MF-000001510
Manufacturer status: Active

Related devices

CME0011954750879CMYHTOn the market CMU0006174750879CMYHTOn the market CMC0002664750879CMYHTOn the market CME0016274750879CMYHTOn the market CMC0003034750879CMYHTOn 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Latvia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04752107000228
Basic UDI-DI: 4750879CMYHT
Reference / catalog number: CME000228
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: Waterproof plasters skin color (assorted), 20 pcs
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 2x7 cm - 5 pcs, 6x2 cm - 10 pcs, diam 2.5cm - 5 pcs

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04752107000228

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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.

M04010199ADHESIVE DRESSINGS, WITH ABSORBENT PAD - 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

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