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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

WasherCap™ Fixation System 10mm — Class IIb MDD

MD Atlas
ABANZA TECNOMED, S.L.

EUDAMED last updated this device on Mar 7, 2023

WasherCap™ Fixation System 10mm

B-08437019739843

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ABANZA TECNOMED, S.L.
UDI-DI code: 08437019739843
Reference / catalog number: ABWC1021

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Manufacturer information

Organization name: ABANZA TECNOMED, S.L.
SRN: ES-MF-000007530
Manufacturer status: Active

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

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

CW001
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW999
USED-BY-DATE

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 1, 2023	May 26, 2024

Device identification

Trade name: WasherCap™ Fixation System 10mm
UDI-DI code: 08437019739843
Basic UDI-DI: B-08437019739843
Reference / catalog number: ABWC1021
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: https://abanzamed.com/wp-content/uploads/2023/01/001-01-07-WSC.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P09120699BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - 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

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