Identity
- Trade Name
- Endoscopic Marker EUDAMED
- Device Name
- Endoscopic Marker EUDAMED
- Model / Reference
- 00711836INT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809380056957 EUDAMED
- Basic UDI-DI
- B-08809380056957 EUDAMED
- EMDN Code
- G030805 GASTROINTESTINAL ENDOSCOPIC TATTOOING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Endoscopic Marker 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-08809380056957 | 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 6ce59ea8-ebed-4b86-9f9d-4d1d70771b12 61 fields · synced Jun 19, 2026