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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

Z5-BL-4012 — Class IIb MDD by Z-Systems AG

MD Atlas
Z-Systems AG

EUDAMED last updated this device on Apr 20, 2026

Z5-BL-4012

B-07640166760825

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Z-Systems AG
UDI-DI code: 07640166760825
Reference / catalog number: Z5-BL-4012

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View device family (Basic UDI)

Manufacturer information

Organization name: Z-Systems AG
SRN: CH-MF-000029012
Manufacturer status: Active

Critical warnings

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

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.

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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: 07640166760825
Basic UDI-DI: B-07640166760825
Reference / catalog number: Z5-BL-4012
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC 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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07640166760825

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

P01020101DENTAL IMPLANTS

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

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Related devices

Z5-BL-3610B-07640166768494On the market Z5-BL-4008B-07640166760801On the market Z5-BL-5010B-07640166760849On the market Z5-BL-3608B-07640166768463On the market Z5-BL-3612B-07640166768524On 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.