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Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR）
EUDAMEDClass C (EU MDR)
Ref BRC-PCR-30-CEModel 30 tests per kit
Identity
- Trade Name
- Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR） EUDAMED
- Model / Reference
- 30 tests per kit EUDAMEDBRC-PCR-30-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970703930093 EUDAMED
- Basic UDI-DI
- 697070393BRC001BU EUDAMED
- Direct Marketing DI
- 06970703930093 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands 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
Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR） by Excellen Medical Technology Co., Ltd. — Class C — IVDR — listed in EUDAMED
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 | 697070393BRC001BU | Class C | Active |
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Manufacturer
- Manufacturer
- Excellen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010402
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 5a4e8495-e314-43eb-8cd8-82760ece5c9b 61 fields · synced Oct 6, 2026