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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

ZERAMEX®XT Rescue-Shell XT REGULAR — Class I MDR

MD Atlas
CeramTec Schweiz GmbH

EUDAMED last updated this device on Apr 24, 2024

ZERAMEX®XT Rescue-Shell XT REGULAR

764016139R981XXK01RS5Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CeramTec Schweiz GmbH
UDI-DI code: 07640161393769
Reference / catalog number: R98100

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Manufacturer information

Organization name: CeramTec Schweiz GmbH
SRN: CH-MF-000024169
Manufacturer status: Active

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
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	Apr 11, 2024	Still on market

Device identification

Trade name: ZERAMEX®XT Rescue-Shell XT REGULAR
UDI-DI code: 07640161393769
Basic UDI-DI: 764016139R981XXK01RS5Y
Reference / catalog number: R98100
Issuing entity: GS1

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: ZERAMEX®XT Rescue-Shell XT REGULAR
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P01020180DENTAL IMPLANTS - ACCESSORIES

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

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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.