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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

S-U-WAX BITE RIMS "T", soft, 100… — Class I MDR

MD Atlas
SCHULER-DENTAL GmbH & Co. KG

EUDAMED last updated this device on May 19, 2026

S-U-WAX BITE RIMS "T", soft, 100 mand.

++D998BISSWTUKW67

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SCHULER-DENTAL GmbH & Co. KG
UDI-DI code: D998610220191
Reference / catalog number: 61022019

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Manufacturer information

Organization name: SCHULER-DENTAL GmbH & Co. KG
SRN: DE-MF-000006405
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 Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
France		Still on market
Italy		Still on market

Device identification

Trade name: S-U-WAX BITE RIMS "T", soft, 100 mand.
UDI-DI code: D998610220191
Basic UDI-DI: ++D998BISSWTUKW67
Reference / catalog number: 61022019
Issuing entity: HIBCC

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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D998610220191

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q01020203OCCLUSAL WAXES

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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On the market

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