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Organization name
UDI-DI code
Reference / catalog number

Demedent Prophy Powder, apple — Class I MDR by VRK Lab GmbH

MD Atlas
VRK Lab GmbH

EUDAMED last updated this device on Apr 20, 2022

Demedent Prophy Powder, apple

426057052PCXG6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VRK Lab GmbH
UDI-DI code: 42605705209718
Reference / catalog number: 26077

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Manufacturer information

Organization name: VRK Lab GmbH
SRN: DE-MF-000010636
Manufacturer status: Active

Critical warnings

8 warnings recorded — scroll inside the panel to see all entries.

CW136
EUDAMED did not publish a description for this code.
CW138
EUDAMED did not publish a description for this code.
CW148
EUDAMED did not publish a description for this code.
CW162
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW397
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: Demedent Prophy Powder, apple
UDI-DI code: 42605705209718
Basic UDI-DI: 426057052PCXG6
Reference / catalog number: 26077
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: Multi-fractional complex prophylaxis powder Demedent Prophy Powder on the base of sodium bicarbonate with precisely selected combination of particles for air polishing technology.
Additional information URL: https://demedent.vrklab.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01010403DENTAL ABRASIVE AND POLISHING MATERIALS

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

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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.