Protex Anatomic Reel

by Sagami Rubber Industries Co., Ltd. Japan EUDAMED

Ref ES5615, ES5616 EMDN U110101

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	Number4974234NRCDM013K Basic UDI-DI	Date14 Feb 2025Registered	StatusActive
European Union	CE/MDR	Number4974234NRCDM013K Basic UDI-DI	Date14 Feb 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Natural rubber latex condom
Model / Reference: ES5615, ES5616

Primary DI / UDI-DI: 03760043366095, 03760043366125
Basic UDI-DI: 4974234NRCDM013K, B-03760043366095, B-03760043366125
Direct Marketing DI: 03760043366095
03760043366125
EMDN Code: U110101 Condoms

Device Class: Class IIb
Market of Registration: France

Manufacturer details

EUDAMED SRN: JP-MF-000040149
Authorised representative: Sagami Europe SAS FR-AR-000038926

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Properties & raw data

Show properties, registry sources and raw records

Contains Latex

Other properties (12)

Sterile: No
Implantable: No
Reusable: 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

Sources (4)

EUDAMED 683aa7d3-37c3-41f2-8d06-6ce0227e0ee9 61 fields · synced 22 Oct 2026
EUDAMED 03760043366125|4974234NRCDM013K 61 fields · synced 17 May 2026
EUDAMED 03760043366095|B-03760043366095 61 fields · synced 13 Jul 2026
EUDAMED 03760043366125|B-03760043366125 61 fields · synced 26 Jul 2026