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Rollator
EUDAMEDClass I (EU MDR)
Ref LETT800M / S1-VOLCANORef LETT900P / S4-MOONRef LETT800M / S6-MARINERef LETT900P / S2-RUBYRef LETT800M / S2-RUBYRef LETT900P / S6-MARINERef LETT800M / S3-ICERef LETT900P / S3-ICE
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- LETT800M / S1-VOLCANO EUDAMEDLETT900P / S4-MOON EUDAMEDLETT800M / S6-MARINE EUDAMEDLETT900P / S2-RUBY EUDAMEDLETT800M / S2-RUBY EUDAMEDLETT900P / S6-MARINE EUDAMEDLETT800M / S3-ICE EUDAMEDLETT900P / S3-ICE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889030065 EUDAMED04719889030034 EUDAMED04719889030119 EUDAMED04719889030010 EUDAMED04719889030072 EUDAMED04719889030058 EUDAMED04719889030089 EUDAMED04719889030027 EUDAMED
- Basic UDI-DI
- 471988903R900PFP EUDAMED
- Direct Marketing DI
- 04719889030065 EUDAMED04719889030034 EUDAMED04719889030119 EUDAMED04719889030010 EUDAMED04719889030072 EUDAMED04719889030058 EUDAMED04719889030089 EUDAMED04719889030027 EUDAMED
- EMDN Code
- Y120609 WALKING FRAMES WITH CHAIR, 4 WHEELS 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
Rollator by Babylove Industrial Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471988903R900PFP | Class I | Active |
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Manufacturer
- Manufacturer
- Babylove Industrial Co., Ltd.
- EUDAMED SRN
- TW-MF-000019120
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (8)
- EUDAMED c22b7a15-81a2-4bfe-b1ce-85a964d44530 61 fields · synced Aug 3, 2026
- EUDAMED 895f9d25-76cc-4dfd-944c-63b579abc212 61 fields · synced May 16, 2026
- EUDAMED c209ee5a-cb57-414d-a7a5-91478e1747b9 61 fields · synced May 17, 2026
- EUDAMED f9a1c1b7-1c4d-407e-a795-a08ad1ad662d 61 fields · synced May 17, 2026
- EUDAMED 346dedd8-65a3-459d-9a70-49d2b4ea8de7 61 fields · synced May 18, 2026
- EUDAMED 32888b9c-26eb-4513-9921-7d24643c3cab 61 fields · synced May 18, 2026
- EUDAMED b1dce139-16eb-493e-8497-6c2491bdf08a 61 fields · synced May 18, 2026
- EUDAMED 1396bb51-cece-4575-a251-085f340c7ddf 61 fields · synced May 19, 2026