3010025

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 3010025Model ENT-single-use suction tubes

by SPIGGLE & THEIS Medizintechnik GmbH

Identity

Trade Name: ENT-single-use suction tubes, angled FDA UDI
Generic Name: Suction/irrigation tubing, single-use FDA UDI
Device Name: rounded tip, suction control on side 100x2.5 mm, sterile, 50 pieces/box FDA UDI
Model / Reference: ENT-single-use suction tubes EUDAMED
3010025 EUDAMEDFDA UDI
Description: rounded tip, suction control on side 100x2.5 mm, sterile, 50 pieces/box FDA UDI

Identifiers

Catalog Number: 3010025 FDA UDI
Primary DI / UDI-DI: 04250676706133 EUDAMEDFDA UDI
Basic UDI-DI: B-04250676706133 EUDAMED
FDA Product Code: BYY FDA UDI
EMDN Code: A060102 SURGICAL DRAINAGE CONNECTION MEDICAL TUBES EUDAMED
GMDN Term: Suction/irrigation tubing, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 880.6740 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Suction/irrigation tubing, single-use

3010025 by SPIGGLE & THEIS Medizintechnik GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suction/irrigation tubing, single-use.

Non-sterile aspiration tubes — Produtos Médicos Hospitalares, SA · Class I
AMSure® Suction Connecting Tube with Pre-Attached Yankauer — AMSINO INTERNATIONAL, INC. · Class II
ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
Bioseal Inc. — BIOSEAL · Class I
Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
Bioseal Inc. — BIOSEAL · Class I

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-04250676706133	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: SPIGGLE & THEIS Medizintechnik GmbH
EUDAMED SRN: DE-MF-000006647

Sources (2)

EUDAMED 30d82eff-63e3-49ce-a6ac-931ef46d6912 61 fields · synced Jul 9, 2026
FDA UDI 66b8ef84-f92e-4275-bc99-b47fe002f428 35 fields · synced May 30, 2026