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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

BK 328 — Class I MDR by Dr. Jean Bausch GmbH &…

MD Atlas
Dr. Jean Bausch GmbH & Co. KG

EUDAMED last updated this device on Apr 2, 2026

BK 328

++E2102x0xFilmx8x12x16D5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Jean Bausch GmbH & Co. KG
UDI-DI code: +E210BK3281H
Reference / catalog number: BK 328

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Manufacturer information

Organization name: Dr. Jean Bausch GmbH & Co. KG
SRN: DE-MF-000005577
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

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

CW009
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: +E210BK3281H
Basic UDI-DI: ++E2102x0xFilmx8x12x16D5
Reference / catalog number: BK 328
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: 20
Additional product description: —
Additional information URL: https://www.bauschdental.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01020299DENTAL CONTACT INDICATORS - 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