BougieCap Set
Part of a family of 8 devices: see the family page
Ref 400.30Model BougieCap
BougieCap Set (400.30) is a Class I device made by Ovesco Endoscopy AG, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 426020631REMV00458) with CE/MDR certificate 1000317372 valid until 16 Nov 2030, active as of 13 Nov 2026.
Active
CE MDR
Valid until
16 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000317372 | Date25 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 426020631REMV00458
Certificates
- 1000317372 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 25 Sep 2026
- Expires
- 16 Nov 2030
- Reason
- Change approved
Timeline
- Registered EUDAMED 426020631REMV00458
- Certificate issued EUDAMED 1000317372
- Certificate expires EUDAMED 1000317372
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- BougieCap, 400.30
- Primary DI / UDI-DI
- 04260206312086
- Basic UDI-DI
- 426020631REMV00458
- EMDN code
- G010101 Oesophageal bougies
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006426
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