← Back to catalogue
FlexCell
EUDAMEDClass I (EU MDR)
Ref 1027201 - 1Model 4 x 550mAh Std Battery – OB style Charging PortRef 1037203 - 1Ref 1027202 - 1Ref 1027203 - 1Ref 1037204 - 1Ref 1027204-1
Identity
- Trade Name
- FlexCell EUDAMED
- Device Name
- FlexCell EUDAMED
- Model / Reference
- 4 x 550mAh Std Battery – OB style Charging Port EUDAMED1027201 - 1 EUDAMED1037203 - 1 EUDAMED1027202 - 1 EUDAMED1027203 - 1 EUDAMED1037204 - 1 EUDAMED1027204-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850004850527 EUDAMED00850004850565 EUDAMED00850004850497 EUDAMED00850004850503 EUDAMED00850004850572 EUDAMED00850004850510 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Infinite Biomedical Technologies LLC
- EUDAMED SRN
- US-MF-000007619
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (6)
- EUDAMED 7baa48e8-3af9-4f7d-9baf-cd2cdd96e7da 61 fields · synced Aug 1, 2026
- EUDAMED 483b6a81-20c8-4e5a-994f-fa24284dd78a 61 fields · synced May 17, 2026
- EUDAMED c3e5749b-febe-428e-bc09-48c64ae9af59 61 fields · synced May 18, 2026
- EUDAMED 2d78a701-d53a-4703-9c37-cddac9957400 61 fields · synced May 18, 2026
- EUDAMED 77e42076-09f3-4da3-a08b-43342e20fc58 61 fields · synced May 18, 2026
- EUDAMED 41f4b30e-32e3-482d-9b95-324886a4eac0 61 fields · synced May 18, 2026