Identity
- Trade Name
- Black Eye Endoscopic Marker Ink EUDAMEDBlack Eye FDA UDI
- Generic Name
- Tissue marking ink FDA UDI
- Device Name
- Black Eye Endoscopic Marker Ink EUDAMED
- Model / Reference
- TS-205 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809380059002 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809380059002 EUDAMED
- FDA Product Code
- NBG FDA UDI
- EMDN Code
- G030805 GASTROINTESTINAL ENDOSCOPIC TATTOOING SYSTEMS EUDAMED
- GMDN Term
- Tissue marking ink FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Black Eye Endoscopic Marker Ink by The Standard Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809380059002 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Standard. Co., Ltd.
- EUDAMED SRN
- KR-MF-000011647
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 5c50d37d-1b5d-4ced-92e8-58b9ae1750b7 61 fields · synced Jul 21, 2026
- FDA UDI f7d3ccf1-47cc-4d40-9e2a-a083f4c9d80d 32 fields · synced May 30, 2026