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Blue Eye Submucosal Injection Agent
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref TS-905510(k) K220434
Identity
- Trade Name
- Blue Eye Submucosal Injection Agent EUDAMEDBlue Eye FDA UDI
- Generic Name
- Submucosal lift solution FDA UDI
- Device Name
- Blue Eye Submucosal Injection Agent EUDAMED
- Model / Reference
- TS-905 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809380050207 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809380050207 EUDAMED
- FDA Product Code
- PLL FDA UDI
- EMDN Code
- G030399 POLYPECTOMY DEVICES - OTHER EUDAMED
- GMDN Term
- Submucosal lift solution FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Finland 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
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
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
Blue Eye Submucosal Injection Agent by The Standard Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220434 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K241591 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809380050207 | Class IIb | Active |
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Manufacturer
- Manufacturer
- The Standard. Co., Ltd.
- EUDAMED SRN
- KR-MF-000011647
- FDA Applicant
- The Standard Co., Ltd.
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED 1990d00e-daf3-47d2-ae15-efe1bc252c50 85 fields · synced Jun 18, 2026
- FDA UDI fa52ef7c-47c2-41b5-be72-d34b4d062d97 32 fields · synced May 30, 2026
- FDA 510(k) K220434 1 fields · synced May 18, 2026