Identity
- Trade Name
- Black Eye Endoscopic Marker Ink EUDAMED
- Device Name
- Black Eye Endoscopic Marker Ink EUDAMED
- Model / Reference
- TS-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809380052478 EUDAMED
- Basic UDI-DI
- B-08809380052478 EUDAMED
- EMDN Code
- G030805 GASTROINTESTINAL ENDOSCOPIC TATTOOING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Black Eye Endoscopic Marker Ink by The Standard Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809380052478 | Class IIb | Active |
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Manufacturer
- Manufacturer
- The Standard. Co., Ltd.
- EUDAMED SRN
- KR-MF-000011647
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 59bc1d27-fa34-4376-b2cb-578ee8e7b658 61 fields · synced Jul 23, 2026