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Organization name
UDI-DI code
Reference / catalog number

SICwhite Drill Stop WB — Class IIa MDR by CeramTec Schweiz GmbH

MD Atlas
CeramTec Schweiz GmbH

EUDAMED last updated this device on Mar 11, 2024

SICwhite Drill Stop WB

764016139XT3X651KL2ADSF5

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CeramTec Schweiz GmbH
UDI-DI code: 07640161396104
Reference / catalog number: 970943

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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.

CW010
EUDAMED did not publish a description for this code.
CW011
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	Mar 15, 2024	Still on market

Device identification

Trade name: SICwhite Drill Stop WB
UDI-DI code: 07640161396104
Basic UDI-DI: 764016139XT3X651KL2ADSF5
Reference / catalog number: 970943
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SICwhite Drill Stop WB
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L0180SHARP INSTRUMENTS, REUSABLE - 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.