Identity
- Trade Name
- Stool Preparation Set FDA UDI
- Generic Name
- Pancreatic elastase (PE) IVD, reagent FDA UDI
- Device Name
- Stool Preparation Kit EUDAMED
- Model / Reference
- ACS-001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04099466400116 EUDAMEDFDA UDI
- Basic UDI-DI
- 4099466ACS001NW EUDAMED
- Direct Marketing DI
- 04099466400116 EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
- GMDN Term
- Pancreatic elastase (PE) IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pancreatic elastase (PE) IVD, reagent
Stool Preparation Set by Seramun Diagnostica GmbH — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Seramun Diagnostica GmbH
Sources (2)
- FDA UDI ff30c6fb-4b1d-4741-b259-de186ff5387b 32 fields · synced Jul 16, 2026
- EUDAMED 620aa03b-bc2d-435a-890d-5af4878b5ec5 61 fields · synced Jul 16, 2026