Thompson SL46198RE

by Thompson Surgical Instruments, Inc.

Ref SL46198REModel Thompson Retractor System

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

18 Dec 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number008415361THM5 Basic UDI-DI 00841536122992UDI-DI	Date5 May 2026Registered	StatusActive
European Union	CE/MDR EUDAMED	Number1000286115	Date5 Feb 2026Issued	StatusActive expires 18 Dec 2029
European Union	CE/MDR EUDAMED	Number1000286127	Date5 Feb 2026Issued	StatusActive expires 18 Dec 2029
United States	GUDID listing GUDID	Number00841536122992 UDI-DI	Date8 Aug 2020Listed	StatusListed GUDID: in commercial distribution

Certificates

2 certificates · EUDAMED

1000286115 Active Supplemented

Technical documentation EU MDR

Certifier

DQS Medizinprodukte GmbH 0297

Issued
5 Feb 2026

Expires
18 Dec 2029

Reason
Other
1000286127 Active Supplemented

Quality management system EU MDR

Certifier

DQS Medizinprodukte GmbH 0297

Issued
5 Feb 2026

Expires
18 Dec 2029

Reason
Other

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: Reverse Lip 32x150mm EUDAMED
Thompson GUDID
Generic Name: Surgical retraction system, reusable
Model / Reference: SL46198RE, Thompson Retractor System

Primary DI / UDI-DI: 00841536122992
Basic UDI-DI: 008415361THM5
Direct Marketing DI: 00841536122992
FDA Product Code: GAD
EMDN Code: L99 Surgical instruments, reusable - other
GMDN Term: Surgical retraction system, reusable

Device Class: Class III EUDAMED
Class I GUDID
Regulation Number: 878.4800
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device Class	EUDAMED Class III	GUDID Class I

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Properties

Reusable
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (20)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No