Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- LETT800M / S5-PINE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889030102 EUDAMED
- Basic UDI-DI
- 471988903R900PFP EUDAMED
- Direct Marketing DI
- 04719889030102 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 (1)
- EUDAMED 566c365b-47d4-45cc-9fb1-a1b4c12dc8c3 61 fields · synced Jun 19, 2026