Olympus MAJ-2220
by KeyMed (Medical and Industrial Equipment) Ltd
Ref K10037161Model INSUFFLATION TUBING
Olympus MAJ-2220 (K10037161) is a device classified as Class IIa in the EU and Class II in the US made by KeyMed (Medical and Industrial Equipment) Ltd, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 5019778MF001009AB) and listed in FDA GUDID since 18 Jul 2023 (UDI-DI 15019778008516), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number5019778MF001009AB 15019778008516 | Date28 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number15019778008516 | Date18 Jul 2023 | StatusListed |
Official records
- EUDAMED public site 5019778MF001009AB
- AccessGUDID record 15019778008516
Across registries
- EUDAMED Basic UDI-DI 5019778MF001009AB registered 28 Oct 2026 Active
- FDA GUDID UDI-DI 15019778008516 listed 18 Jul 2023 Listed
Timeline
- Listed FDA GUDID 15019778008516
- Registered EUDAMED 5019778MF001009AB
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Insufflation Tubing with CO2 Maj-2220 - PK10 EUDAMEDOlympus GUDID
- Generic name
- Endoscopic insufflation tubing set, single-use
- Model / Ref / Catalog
- INSUFFLATION TUBING, K10037161, MAJ-2220
- Primary DI / UDI-DI
- 15019778008516
- Basic UDI-DI
- 5019778MF001009AB
- FDA product code
- OCX
- EMDN code
- G0380 Digestive endoscopy devices - accessories
- GMDN term
- Endoscopic insufflation tubing set, single-use
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 876.1500
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | INSUFFLATION TUBING K10037161 | MAJ-2220 |
| Device class | Class IIa | Class II |
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