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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

Universal TENS — Class IIa MDR by Verity Medical Ltd.

MD Atlas
Verity Medical Ltd.

EUDAMED last updated this device on May 2, 2024

Universal TENS

506007397ECS300AZ5

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Verity Medical Ltd.
UDI-DI code: 05060073970582
Reference / catalog number: OPH300A

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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.
CW014
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.

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: Universal TENS
UDI-DI code: 05060073970582
Basic UDI-DI: 506007397ECS300AZ5
Reference / catalog number: OPH300A
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 Kegel8®Ultra506007397ETS2004COn 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.