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

WasherCap™ Fixation System 7mm — Class IIb MDD

MD Atlas
ABANZA TECNOMED, S.L.

EUDAMED last updated this device on Jun 9, 2023

WasherCap™ Fixation System 7mm

B-08437019739812

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ABANZA TECNOMED, S.L.
UDI-DI code: 08437019739812
Reference / catalog number: ABWC0721

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

Related devices

Inserter Coupling Screw 7mm & 8mmB-08437019739553On the market Awl 7mm & 8mmB-08437019739515On the market Awl 9mm & 10mmB-08437019739539On the market Countersink Tool8437019739ATMWCIN7836On the market Handle with AO connection sytem8437019739ATMWCIN452POn 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

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 7mm
UDI-DI code: 08437019739812
Basic UDI-DI: B-08437019739812
Reference / catalog number: ABWC0721
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