Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

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

MD Atlas
CeramTec Schweiz GmbH

EUDAMED last updated this device on Apr 24, 2024

ZERAMEX®XT Rescue-Shell XT SMALL

764016139R981XXK01RS5Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CeramTec Schweiz GmbH
UDI-DI code: 07640161395077
Reference / catalog number: R98120

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

CERALOG® PL Implant driver, ISO-shaft L 22.8 mm764016139XT3XXXXKL2APIFWOn the market CERALOG® PL Implant driver, ISO-shaft L 27.8 mm764016139XT3XXXXKL2APIFWOn the market CERALOG® PL Implant removal driver L 23.0 mm764016139XT3XXXXKL2APIFWOn the market CERALOG® PL Impression post closed tray Ø 3.8 mm L 7.8 mm764016139XB3YYYYK01IPETOn the market CERALOG® PL Impression post closed tray Ø 4.3 mm L 7.8 mm764016139XB3YYYYK01IPETOn 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.

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 SMALL
UDI-DI code: 07640161395077
Basic UDI-DI: 764016139R981XXK01RS5Y
Reference / catalog number: R98120
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 SMALL
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