Prolene
by Ethicon, LLC. EUDAMED
Active
Ref EH7383HModel PROLENE Suture
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 719658 | Date5 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Not drawn on the map: Northern Ireland.
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Certificates
- MDR 719658 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 5 Jun 2026
- Expires
- 4 Jul 2028
- Reason
- Other
Specification
- Device Name
- PROLENE Suture
- Model / Reference
- PROLENE Suture, EH7383H
- Primary DI / UDI-DI
- 10705031096172
- Basic UDI-DI
- 0705031a012574X
- EMDN Code
- H010201010401,H010201010402
- Device Class
- Class III
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000013111
- Authorised representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Other devices from Ethicon Inc.
Properties
Other properties (11)
- Reusable: 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