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Organization name
UDI-DI code
Reference / catalog number

UnoDent Unowipes — Class IIa MDR by Schülke & Mayr GmbH

MD Atlas
Schülke & Mayr GmbH

EUDAMED last updated this device on Mar 24, 2026

UnoDent Unowipes

4032651BSC000000209Y

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Schülke & Mayr GmbH
UDI-DI code: 04032651986972
Reference / catalog number: 70004107

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Manufacturer information

Organization name: Schülke & Mayr GmbH
SRN: DE-MF-000005701
Manufacturer status: Active

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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.

Critical warnings

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

CW058
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW091
EUDAMED did not publish a description for this code.
CW999
not suitable for final disinfection of semicritical and critical medical devices.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: UnoDent Unowipes
UDI-DI code: 04032651986972
Basic UDI-DI: 4032651BSC000000209Y
Reference / catalog number: 70004107
Issuing entity: GS1

Classification

Risk category: Class IIa
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.

EMDN nomenclature code(s)

D0799ALCOHOLS FOR THE DISINFECTION OF MEDICAL DEVICES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification