PROFOUND™ A - Sterilized Poly(Lactide-Co-Glycolide) Absorbable Mesh Fixation Device
by Meril Endo Surgery Pvt. Ltd.
Ref ME/BRC/009
Active
CE MDR
Valid until
4 May 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000316736 | Date10 Sep 2026 | StatusActive |
Certificates
- 1000316736 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 10 Sep 2026
- Expires
- 9 Sep 2031
- 1000333405 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 10 Sep 2026
- Expires
- 4 May 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
EU market availability
Made available in 1 country, as listed in EUDAMED:
- Spain since 19 Apr 2019
Specification
- Model / Reference
- ME/BRC/009
- Primary DI / UDI-DI
- 18904255219523, 18904255219509
- Basic UDI-DI
- 89042552MES_MFA20TP
- EMDN Code
- P058001 Oesophageal and gastrointestinal prostheses positioning devices
- Device Class
- Class III
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- IN-MF-000010999
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Meril Endo Surgery Pvt. Ltd.
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