MEDIPIN LIMITED

Address:24 CHILTERN AVENUE,BUSHEY Hertfordshire,GB

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Esthesiometer (GXB) (2)

Premarket Exempt

Yes

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Medipin - 05060631140006 Catalog Number : MP-100

Device Description : A box of 100 Single-Use Protected Neurological Pins - A disposable precision ins A box of 100 Single-Use Protected Neurological Pins - A disposable precision instrument for testing cutaneous pinprick sensation designed to optimise the patient's perception of sharpness without piercing delicate skin for use in the clinical or non-clinical setting. GMDN Definition: A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device.

Device Class :

Duns Number: 737328851

Premarket Exempt : Yes

Product Code : GXB

Prescription Use : No

Device Count : 100

Medipin - 05060631140013 Catalog Number : MP-12

Device Description : A carton of 12 Single-Use Protected Neurological Pins intended to allow patients A carton of 12 Single-Use Protected Neurological Pins intended to allow patients with diabetes to test themselves safely at home monthly for early signs of diabetic neuropathy according to American Diabetes Association guidelines - A disposable precision instrument for testing cutaneous pinprick sensation designed to optimise the patient's perception of sharpness without piercing delicate skin for use in the clinical or non-clinical setting. GMDN Definition: A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device.

Device Class :

Duns Number: 737328851

Premarket Exempt : Yes

Product Code : GXB

Prescription Use : No

Device Count : 12

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