Oti Faes CalmaDol
by EmergoPharm Spółka z ograniczoną odpowiedzialnością Sp. K.
Active
CE MDR CE MDD
Valid until
18 May 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberTNP/MDR/0054/5756/2026 | Date26 Aug 2026 | StatusActive |
| European Union | CE/MDD | NumberB-05902020885993 05902020885993 | Date23 Apr 2026 | StatusActive |
Certificates
- TNP/MDR/0054/5756/2026 Active
Quality management system EU MDR
- Certifier
- TUV NORD Polska Sp. z o.o 2274
- Issued
- 5 Aug 2026
- Expires
- 18 May 2031
- Reason
- Add device or group
- TNP/MDR/0054/5756/2026 Active
Quality management system EU MDR
- Certifier
- TUV NORD Polska Sp. z o.o 2274
- Issued
- 26 Aug 2026
- Expires
- 18 May 2031
- Reason
- Add device or group
- TNP/MDR/0060/5756/2026 Active
Technical documentation EU MDR
- Certifier
- TUV NORD Polska Sp. z o.o 2274
- Issued
- 6 Aug 2026
- Expires
- 18 May 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- Oti Faes CalmaDolOtifaes Calmadol
- Device Name
- Auridol
- Primary DI / UDI-DI
- 05902020885993
- Basic UDI-DI
- B-05902020885993, 5902020885058X
- EMDN Code
- M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
- Device Class
- Class III
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000007178
Other devices from EmergoPharm Spółka z ograniczoną odpowiedzialnością Sp. K.
Properties
Other properties (12)
- 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