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FlexCell
EUDAMEDClass I (EU MDR)
Ref 1037202 - 1Model 4 x 550mAh Std Battery – OB style Charging Port
Identity
- Trade Name
- FlexCell EUDAMED
- Device Name
- FlexCell EUDAMED
- Model / Reference
- 4 x 550mAh Std Battery – OB style Charging Port EUDAMED1037202 - 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850004850558 EUDAMED
- Basic UDI-DI
- 850004850FLEXCELLR4 EUDAMED
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
FlexCell by Infinite Biomedical Technologies LLC — 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 | 850004850FLEXCELLR4 | Class I | Active |
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Manufacturer
- Manufacturer
- Infinite Biomedical Technologies LLC
- EUDAMED SRN
- US-MF-000007619
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED f6f91396-4031-4efe-8d47-6ab0124833b8 61 fields · synced Jun 19, 2026