← Back to catalogue
e-fix
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1595821Model e-fix E35Ref 1595681Ref 1595814Model e-fix E36Ref 1595823Ref 1595686Ref 1595684Ref 1595695Ref 1595811Ref 1595693Ref 1566299Ref 1566894
by Alber GmbH
Identity
- Trade Name
- e-fix EUDAMEDe-fix® FDA UDI
- Generic Name
- Wheelchair electric-motor-driven propulsion system FDA UDI
- Device Name
- e-fix E35 EUDAMEDe-fix E36 EUDAMED
- Model / Reference
- e-fix E35 EUDAMED1595821 EUDAMED1595681 EUDAMEDe-fix E36 EUDAMED1595814 EUDAMED1595823 EUDAMED1595686 EUDAMED1595684 EUDAMED1595695 EUDAMED1595811 EUDAMED1595693 EUDAMED1566299 EUDAMED1566894 EUDAMEDE35/E36 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046727256630 EUDAMED04046727250928 EUDAMED04046727256562 EUDAMED04046727256654 EUDAMED04046727250966 EUDAMED04046727250959 EUDAMED04046727251055 EUDAMED04046727256531 EUDAMED04046727251048 EUDAMED04046727172923 EUDAMEDFDA UDI04046727167509 EUDAMEDFDA UDI
- Basic UDI-DI
- 4046727e-fixE35QZ EUDAMED4046727e-fixE36R3 EUDAMED
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122410 ELECTRIC PROPULSION UNIT EUDAMED
- GMDN Term
- Wheelchair electric-motor-driven propulsion system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Market of Registration
- Germany EUDAMEDSweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
e-fix by Alber GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4046727e-fixE35QZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alber GmbH
- EUDAMED SRN
- DE-MF-000005502
Sources (13)
- EUDAMED dbb57efd-fd64-4a77-bdbf-60bd3bfb973c 61 fields · synced Jul 28, 2026
- EUDAMED 5d92ae16-7432-4150-a308-4f7c5faf6dca 61 fields · synced May 17, 2026
- EUDAMED b205e1fc-bb3d-4e31-b839-5f918291fbbc 61 fields · synced May 17, 2026
- EUDAMED 19d7a423-25e9-450f-929c-27a85773a8e0 61 fields · synced May 17, 2026
- EUDAMED c24aec00-b669-4bea-a61b-f86f420d2a85 61 fields · synced May 18, 2026
- EUDAMED c38fab8f-126f-4d0f-9006-d77ad768f546 61 fields · synced May 18, 2026
- EUDAMED b7f65250-f393-4395-9f0f-3ea1eecaec41 61 fields · synced May 18, 2026
- EUDAMED 1a1389ae-0664-412d-a6a1-e3987b81f106 61 fields · synced May 18, 2026
- EUDAMED 7387fe26-3570-4033-b8df-a0880f08d82a 61 fields · synced May 18, 2026
- FDA UDI b4367452-4da8-4d1a-996b-e6dd93626972 32 fields · synced May 30, 2026
- FDA UDI fd166a46-a86f-4c89-80a1-d6fb2bd73c41 32 fields · synced May 30, 2026
- EUDAMED f2857594-e4ef-45ff-84b4-91ccf4690c1a 61 fields · synced Jul 9, 2026
- EUDAMED 585a4033-0153-4878-99fa-b7d4f3cebb03 61 fields · synced Jul 9, 2026