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EndoLIF® Delta-Cage 11 4°
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ELDL6425114
by Joimax GmbH
Identity
- Trade Name
- EndoLIF® Delta-Cage 11 4° EUDAMEDEndoLIF® FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- EndoLIF® Delta-Cage 11 4° EUDAMEDFDA UDI
- Model / Reference
- ELDL6425114 EUDAMEDFDA UDI
- Description
- EndoLIF® Delta-Cage 11 4° FDA UDI
Identifiers
- Catalog Number
- ELDL6425114 FDA UDI
- Primary DI / UDI-DI
- 04250337114765 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337114765 EUDAMED
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- P09070101 SPINAL CAGES EUDAMED
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
EndoLIF® Delta-Cage 11 4° by Joimax GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337114765 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (2)
- EUDAMED ac239321-9dd2-4b02-b816-9c2615138740 61 fields · synced Jul 8, 2026
- FDA UDI 18a2dd82-67e5-4a39-8ac3-bc32b3e908eb 36 fields · synced May 30, 2026