Perfect PFE for men (Nordic)

EUDAMED

Class IIa (EU MDR)

Ref K-PPFE-MEN NORDICRef K-PPFE-MEN NORDIC

Identity

Trade Name: Perfect PFE for men (Nordic) EUDAMED
Perfect PFE for men EUDAMED
Device Name: Perfect PFE EUDAMED
Model / Reference: K-PPFE-MEN NORDIC EUDAMED

Primary DI / UDI-DI: 05033435134014 EUDAMED
05033435139750 EUDAMED
05033435132966 EUDAMED
Basic UDI-DI: 5033435K00051ZF EUDAMED
5033435K00053ZK EUDAMED
EMDN Code: U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED

Device Class: Class IIa EUDAMED
Market of Registration: Denmark EUDAMED
Medical Purpose: The perfect PFE is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal probe with stainless steel electrodes. These signals make your pelvic floor muscles contract. If you have forgotten how to contract them, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the perfect PFE can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. EUDAMED

Sterile

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Implantable

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Reusable

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Contains Latex

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Reprocessed

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CMR Substance

EUDAMED

Human-derived

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Human Tissues

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Animal Tissues

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Endocrine Disruptor

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Administering Medicine

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Measuring Function

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Incorporates Medicinal Product

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Perfect PFE for men (Nordic) by TensCare Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	5033435K00051ZF	Class IIa	Active

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