Emorsan Gel (30 ml tube + 1 anal applicator)
Ref 1DEP00950Model 1 tube of 30 ml + anal applicator; 10 single-dose vials of 2.2 ml each; Free sample - not for sale (1 tube of 10 ml + anal applicator); Free sample - not for sale (1 single-dose vial of 2.2 ml)
Active
CE MDR
Valid until
16 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 000128-A | Date16 Jul 2026 | StatusActive |
Certificates
- MDR 000128-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 16 Jul 2026
- Expires
- 16 Nov 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Gel-based medical devices for the protection of the anal mucosa
- Model / Reference
- 1 tube of 30 ml + anal applicator, 10 single-dose vials of 2.2 ml each, Free sample - not for sale (1 tube of 10 ml + anal applicator), Free sample - not for sale (1 single-dose vial of 2.2 ml), 1DEP00950
- Primary DI / UDI-DI
- 08050046270075
- Basic UDI-DI
- 805004627DEPOFARMA009504R
- EMDN Code
- M04040502 Hydrogel dressings, combined with other substances
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000027122
Other devices from Depofarma S.P.A.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- 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