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

Kegel8®Ultra — Class IIa MDR by Verity Medical Ltd.

MD Atlas
Verity Medical Ltd.

EUDAMED last updated this device on May 23, 2024

Kegel8®Ultra

506007397ETS2004C

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Verity Medical Ltd.
UDI-DI code: 05060073970544
Reference / catalog number: OPH200

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: Verity Medical Ltd.
SRN: IE-MF-000007426
Manufacturer status: Active

Critical warnings

5 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.
CW030
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in XI; available across 1 country total.

Country	On market since	Until
XIPrimary placement		Still on market

Device identification

Trade name: Kegel8®Ultra
UDI-DI code: 05060073970544
Basic UDI-DI: 506007397ETS2004C
Reference / catalog number: OPH200
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062899NEUROMUSCULAR STIMULATION EQUIPMENT - 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

Related devices

Kegel8® Mother Nurture506007397OPH3104VOn the market Kegel8® MultiTone506007397OPH120P8UOn the market Kegel8® Ultra 20506007397OPH2024ROn the market Kegel8® V for Men506007397OPH22555On the market NeuroTrac PC Software506007397NTS5008GOn 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.