Organization name

Epimed International, Inc.

SRN

US-MF-000010774

Manufacturer status

Active

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

• Do not re-use
• Do not use if package is damaged
• Do not use past indicated date
• MR UNSAFE
• Refer to instruction manual/booklet

Primary placement in Netherlands; available across 31 countries total.

Trade name

Epimed International,Inc.

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.

00818788021250

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.

081878802SGECH6

Reference / catalog number

166-2024

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 IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Spirol® Close End 20g x 24" (61cm)

Additional information URL

https://www.epimed.com/

Clinical sizes

• 2.7 MU170
• 61 MU10

1 packaging level registered — each level carries its own UDI-DI.

• 00818788021250× 1 unitBase unit
  • 10818788021257× 10 units

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

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

• N010401PERIPHERAL NERVOUS SYSTEM CATHETERS AND KITS

• Class IIb medical devices in EUDAMED

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