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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

CME000095 — Class I MDR by Elvika

MD Atlas
Elvika

EUDAMED last updated this device on Nov 19, 2024

CME000095

4750879CMYHT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Elvika
UDI-DI code: 04750879000095
Reference / catalog number: CME000095

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View device family (Basic UDI)

Manufacturer information

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

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 3 countries total.

Country	On market since	Until
LatviaPrimary placement		Still on market
Estonia		Still on market
Lithuania		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04750879000095
Basic UDI-DI: 4750879CMYHT
Reference / catalog number: CME000095
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 (5 sizes, assorted), 42 pcs
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 2x7 cm - 10 pcs, 6x2 cm - 10 pcs, 4x1 cm - 10 pcs, diam.2.5 cm - 10 pcs, 3.8x3.8 cm - 2 pcs.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04750879000095

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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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