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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

40011 — Class I MDR by Karl Berg GmbH

MD Atlas
Karl Berg GmbH

EUDAMED last updated this device on Dec 8, 2021

40011

426075024BissRegPlatM4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Karl Berg GmbH
UDI-DI code: +EBER40011
Reference / catalog number: 40011

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Manufacturer information

Organization name: Karl Berg GmbH
SRN: DE-MF-000005811
Manufacturer status: Active

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: not provided
UDI-DI code: +EBER40011
Basic UDI-DI: 426075024BissRegPlatM4
Reference / catalog number: 40011
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.

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

Related devices

40010426075024BissRegPlatM4On the market 40001426075024BissRegCMOn the market 40000426075024BissRegCMOn the market 40003426075024BissRegCMOn the market 40002426075024BissRegCMOn 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.