Identity
- Trade Name
- Diacap® EUDAMEDFDA UDI
- Generic Name
- Hollow-fibre haemodialysis dialyser, single-use FDA UDI
- Device Name
- Diacap Pro MDR EUDAMEDDiacap Pro 16H FDA UDI
- Model / Reference
- 720DH16G EUDAMEDFDA UDI
- Description
- Diacap Pro 16H FDA UDI
Identifiers
- Catalog Number
- 720DH16G FDA UDI
- Primary DI / UDI-DI
- 04046955659630 EUDAMED04046955659647 FDA UDI
- Basic UDI-DI
- 40392390000019833H EUDAMED
- FDA Product Code
- KDI FDA UDI
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
- GMDN Term
- Hollow-fibre haemodialysis dialyser, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5860 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
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
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
No
FDA UDI
Diacap® by B.Braun Avitum AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40392390000019833H | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 40392390000019833H | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B. Braun Avitum AG
- EUDAMED SRN
- DE-MF-000005127
Sources (2)
- EUDAMED 260e8ee5-8a4a-4d75-a3d3-92bd38e35fbf 61 fields · synced May 31, 2026
- FDA UDI 809be6e6-866b-474b-b35a-cd521b2a274d 37 fields · synced May 29, 2026