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Estrogen Receptor Antibody Reagent (Immunohistochemistry)
EUDAMEDClass IVD General (EU MDR)
Ref DMRD0191
Identity
- Trade Name
- Estrogen Receptor Antibody Reagent (Immunohistochemistry) EUDAMED
- Device Name
- Estrogen Receptor Antibody Reagent (Immunohistochemistry) EUDAMED
- Model / Reference
- DMRD0191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975503522127 EUDAMED
- Basic UDI-DI
- B-06975503522127 EUDAMED
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Estrogen Receptor Antibody Reagent (Immunohistochemistry) by Shenzhen Dartmon Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975503522127 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dartmon Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019183
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 0b444e84-78f2-483e-a873-488ce670bb61 61 fields · synced Oct 8, 2026