← Back to catalogue
Tissue-Tek Genie®
EUDAMEDClass C (EU MDR)
Ref 8388-C010Model Tissue-Tek Genie® anti-HER2 Rabbit Monoclonal Antibody [EP3]
Identity
- Trade Name
- Tissue-Tek Genie® EUDAMED
- Device Name
- Tissue-Tek Genie® anti-HER2 Rabbit Monoclonal Antibody [EP3] EUDAMED
- Model / Reference
- Tissue-Tek Genie® anti-HER2 Rabbit Monoclonal Antibody [EP3] EUDAMED8388-C010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00615233010599 EUDAMED
- Basic UDI-DI
- 06152338271JF EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands 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
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Preferentially expressed antigen in melanoma (PRAME) IVD, antibody.
- PG I Rapid Quantitative Test (Chemiluminescence Immunoassay) — Xiamen Biotime Biotechnology Co., Ltd. · IVD General
- PRAME [EPR20330] — BIOCARE MEDICAL, LLC · Class I
- PG II Rapid Quantitative Test (Chemiluminescence Immunoassay) — Xiamen Biotime Biotechnology Co., Ltd. · IVD General
- S100 Assay Kit (Chemiluminescent Immunoassay) — Sichuan Orienter Biotechnology Co., Ltd. · IVD General
- iFlash-Total β HCG — SHENZHEN YHLO BIOTECH CO., LTD. · Class C
- PG I Rapid Quantitative Test (Chemiluminescence Immunoassay) — Xiamen Biotime Biotechnology Co., Ltd. · IVD General
- Nucleic Acid Detection Kit for Human Papillomavirus 1618 and other 12 High-Risk Genotyping — BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC · IVD General
- Rabbit Monoclonal Anti-Human PRAME — EPITOMICS, INC. · Class I
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 | 06152338271JF | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
- EUDAMED SRN
- US-MF-000022208
- Authorised Representative
- Sakura Finetek Europe B.V. NL-AR-000007853
Sources (1)
- EUDAMED 80f70177-3229-4331-b22d-39edbb648c2c 61 fields · synced May 21, 2026