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Bolus
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 72225Model ManyRef BLS-3005Ref KAC-31052Ref KAC-31202Ref RKB-4005Ref KA31102Ref 72227Ref RKB-3005Ref KAC-31102Ref KA31052Ref RKB-3015Ref RKB-4305Ref KSR-3005R
Identity
- Device Name
- Bolus EUDAMED
- Model / Reference
- Many EUDAMED72225 EUDAMEDBLS-3005 EUDAMEDKAC-31052 EUDAMEDKAC-31202 EUDAMEDRKB-4005 EUDAMEDKA31102 EUDAMED72227 EUDAMEDRKB-3005 EUDAMEDKAC-31102 EUDAMEDKA31052 EUDAMEDRKB-3015 EUDAMEDRKB-4305 EUDAMEDKSR-3005R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920824165560 EUDAMED06920824102206 EUDAMED06920824165621 EUDAMED06920824165645 EUDAMED06920824165911 EUDAMED06920824165614 EUDAMED06920824165577 EUDAMED06920824145043 EUDAMED06920824165638 EUDAMED06920824165607 EUDAMED06920824155868 EUDAMED06920824165928 EUDAMED06920824165690 EUDAMED
- Basic UDI-DI
- 692082410035C7 EUDAMED
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bolus by Klarity Medical & Equipment（GZ） Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202747 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 692082410035C7 | Class I | Active |
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Manufacturer
- Manufacturer
- Klarity Medical & Equipment（GZ） Co., Ltd.
- EUDAMED SRN
- CN-MF-000002229
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (14)
- EUDAMED f1f4637b-27ea-4ee6-ac48-6cad0ba5c2a6 61 fields · synced Oct 6, 2026
- EUDAMED 756923ef-2157-40f5-8f58-0c0e0d56ef26 61 fields · synced May 16, 2026
- EUDAMED 54156fd3-216c-417b-8039-2545a570426e 61 fields · synced May 16, 2026
- EUDAMED e27bf019-5406-4d00-ae46-5367969c4c21 61 fields · synced May 17, 2026
- EUDAMED 00a8d34d-e48b-443e-a3ba-0073f9424869 61 fields · synced May 17, 2026
- EUDAMED a042bf97-42d9-49bd-ae3f-df4c7a2c8ddd 61 fields · synced May 17, 2026
- EUDAMED f5ec285f-41cf-4511-a894-b2a3ad42154f 61 fields · synced May 18, 2026
- EUDAMED 43731778-c30a-49a1-be24-4bf8e85d2f8b 61 fields · synced May 18, 2026
- EUDAMED 47654d94-7e41-42ea-9b39-454fb5efaa8d 61 fields · synced May 18, 2026
- EUDAMED ffc6b837-3c64-41f7-8ee8-e61d951372ad 61 fields · synced May 18, 2026
- EUDAMED 4a96cbbe-b43d-48d1-9dca-b21ab0a49795 61 fields · synced May 18, 2026
- EUDAMED d953c9f4-28e9-465b-bf5e-95870fd57685 61 fields · synced May 19, 2026
- EUDAMED 494016c1-cb88-4586-ab4e-6ae23c019632 61 fields · synced May 19, 2026
- FDA 510(k) K202747 1 fields · synced May 18, 2026