Smoke Filter

EUDAMEDFDA UDI

Class I (EU MDR)

Ref PS3604Model TF-1010

by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited

Identity

Trade Name: Smoke Filter EUDAMEDFDA UDI
Generic Name: Suction system filter, plume particulate FDA UDI
Device Name: Smoke Filter EUDAMED
The Smoke Filter enables simple, safe and effective removal of this surgical smoke during laparoscopic surgical procedures FDA UDI
Model / Reference: TF-1010 EUDAMED
PS3604 EUDAMEDFDA UDI
Description: The Smoke Filter enables simple, safe and effective removal of this surgical smoke during laparoscopic surgical procedures FDA UDI

Identifiers

Catalog Number: PS3604 FDA UDI
Primary DI / UDI-DI: 05051223004110 EUDAMEDFDA UDI
Basic UDI-DI: B-05051223004110 EUDAMED
FDA Product Code: GCJ FDA UDI
EMDN Code: K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
GMDN Term: Suction system filter, plume particulate FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Smoke Filter by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05051223004110	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
EUDAMED SRN: GB-MF-000012819
Authorised Representative: Advena Limited MT-AR-000000234

Sources (2)

EUDAMED 7de4d81b-76b3-4282-bada-35830bdfb605 61 fields · synced Jun 18, 2026
FDA UDI f4ab9eef-45b2-4509-ad53-9471aed9360c 34 fields · synced May 30, 2026