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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

Bitewax Rims red, hard, Large 100 — Class I MDR

MD Atlas
MORSA Wachswarenfabrik Sallinger GmbH

EUDAMED last updated this device on Jul 31, 2024

Bitewax Rims red, hard, Large 100

++D991DW82435NG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MORSA Wachswarenfabrik Sallinger GmbH
UDI-DI code: +D991DB9002M
Reference / catalog number: DBSH0900

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Manufacturer information

Organization name: MORSA Wachswarenfabrik Sallinger GmbH
SRN: DE-MF-000028586
Manufacturer status: Active

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Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: Bitewax Rims red, hard, Large 100
UDI-DI code: +D991DB9002M
Basic UDI-DI: ++D991DW82435NG
Reference / catalog number: DBSH0900
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: 100
Additional product description: Die Dentalwachse werden zur Bissregistrierung und Bissnahme sowie zum Schutz der Schleimhaut eingesetzt.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01020199DENTAL IMPRESSION MATERIALS - 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
Serial number
Software identification

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.