Identity
- Device Name
- Extraction buffer (10x) EUDAMED
- Model / Reference
- ACS-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099466400215 EUDAMED
- Basic UDI-DI
- 4099466ACS002NY EUDAMED
- Direct Marketing DI
- 04099466400215 EUDAMED
- EMDN Code
- W0102069009 ELASTASE (PANCREATIC POLYPEPTIDE) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Extraction buffer (10x) by Seramun Diagnostica GmbH — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4099466ACS002NY | Class A | Active |
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Manufacturer
- Manufacturer
- Seramun Diagnostica GmbH
- EUDAMED SRN
- DE-MF-000026029
Sources (1)
- EUDAMED 1c554696-1fc9-4089-b92f-2f9720ed13ae 61 fields · synced Jun 19, 2026