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Organization name
UDI-DI code
Reference / catalog number

121610 — Class IIb MDR by Schülke & Mayr GmbH

MD Atlas
Schülke & Mayr GmbH

EUDAMED last updated this device on Mar 13, 2026

121610

4032651BSC00000032A7

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Schülke & Mayr GmbH
UDI-DI code: 04032651216109
Reference / catalog number: 121610

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Manufacturer information

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

Critical warnings

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

CW999
should not be used in patients with known or suspected allergy to one or more ingredients.
CW999
must not be applied on cartilage, in the ear and nose and must not be allowed to enter the eye
CW999
Not for oral use

Market distribution

Primary placement in Romania; available across 2 countries total.

Country	On market since	Until
RomaniaPrimary placement		Still on market
Croatia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04032651216109
Basic UDI-DI: 4032651BSC00000032A7
Reference / catalog number: 121610
Issuing entity: GS1

Classification

Risk category: Class IIb
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)

Z12019003WOUND TREATMENT EQUIPMENT

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

Related devices

Adapter for thermosept PAA4032651BSC000000109VOn the market 1139404032651BSC000000209YOn the market antifect N liquid4032651BSC000000209YOn the market antifect N liquid4032651BSC000000209YOn the market 700034004032651BSC00000018ADOn 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.