Organization name

Paramount Surgimed Limited

SRN

IN-MF-000021682

Manufacturer status

Active

8 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Do not resterilize
• Do not re-use

  Re-sterilization and re-use of device may not meet the intended use as blade sharpness may be blunt.

• Caution, sharp edges
• Biological risks

  For single use only, if re-used this can work as carrier for communicable disease, HIV, Hepatitis, contagious disease, undue diseases to patient and/or user.

• Do not use if package is damaged

  Sterility of product is not guaranteed if packet is broken/torn.

• After use of products must be disposed of as per country law of bio-waste handling rule.

  OTHER

• Adverse event may be happened if blades are used after expiry date as expiry date of product is expiry date of sterility.

  OTHER

Primary placement in France; available across 13 countries total.

Trade name

Nextech

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08903175091571

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-08903175091571

Reference / catalog number

BPS2.0

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A01020302CUTANEOUS BIOPSY PUNCHES, SINGLE-USE

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.