Identity
- Trade Name
- Colosafe EUDAMED
- Device Name
- Stool Preservation Solution EUDAMEDMethylation Detection Kit for Human SDC2 Gene (Real Time PCR) EUDAMED
- Model / Reference
- KLM-100201 EUDAMEDKLM-300110；KLM-300190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974591041039 EUDAMEDD-KLM-300110;KLM-300190XX EUDAMED
- Basic UDI-DI
- 6974591041002AS EUDAMEDB-KLM-300110;KLM-300190XX EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
Colosafe by Creative Biosciences (Guangzhou) Co., Ltd. — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6974591041002AS | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 6974591041002AS | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Creative Biosciences (Guangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000034058
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 1f654e64-1bca-4a4f-9563-5fa7f8e3cfca 61 fields · synced Jul 30, 2026
- EUDAMED 17baf482-cc5e-4493-a808-702a4d1d46f9 61 fields · synced May 11, 2026