Prolene
Ref M8967Model PROLENE Suture
Active
CE MDR
Valid until
19 Jul 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 753191 | Date19 Jun 2026 | StatusActive |
Certificates
- MDR 753191 Active
Technical documentation EU MDR
- Notified body
- BSI Group The Netherlands B.V. 2797
- Issued
- 19 Jun 2026
- Expires
- 19 Jul 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- PROLENE Suture
- Model / Reference
- PROLENE Suture, M8967
- Primary DI / UDI-DI
- 10705031073975
- Basic UDI-DI
- 0705031a012584Z
- EMDN Code
- H010201010401, H010201010402
- Device Class
- Class III
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000013112
- 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