Identity
- Trade Name
- Y-Kelin® EUDAMEDY-Kelin FDA UDI
- Generic Name
- Karaya denture adhesive FDA UDI
- Device Name
- Denture Adhesive Powder EUDAMEDProduct Name:Y-kelin Denture Adhesive Powder. Composition: Sodium Alginate. Scope of applicable: Special denture adhesive, a temporary auxiliary denture retentive material. Product Features: Supper extra strength keeps dentures secure. Easy to use.No added colors and flavor,does not affect taste. Directions: 1.Clean and moisten your dentures thoroughly. 2.Tilt the powder bottle mouth towards the denture support, gently tap on the bottle body by index finger, then evenly spray the appropriate adhesive powder to the surface of the denture support. 3. Insert denture into mouth and bite firmly for several seconds. Applicable People: For complete dentures. Store: keep in cool and dry place. Specification: 25g Expiry date: in 24 months. Manufacturer: Anhui Greenland Biotech Co.,Ltd. Add: Mohekou Industrial Zone, Bengbu, Anhui, China. Tel:0552-5875300 FDA UDI
- Model / Reference
- 10g/box，25g/box, 50g/box EUDAMEDN/A EUDAMED25g/Box FDA UDI
- Description
- Product Name:Y-kelin Denture Adhesive Powder. Composition: Sodium Alginate. Scope of applicable: Special denture adhesive, a temporary auxiliary denture retentive material. Product Features: Supper extra strength keeps dentures secure. Easy to use.No added colors and flavor,does not affect taste. Directions: 1.Clean and moisten your dentures thoroughly. 2.Tilt the powder bottle mouth towards the denture support, gently tap on the bottle body by index finger, then evenly spray the appropriate adhesive powder to the surface of the denture support. 3. Insert denture into mouth and bite firmly for several seconds. Applicable People: For complete dentures. Store: keep in cool and dry place. Specification: 25g Expiry date: in 24 months. Manufacturer: Anhui Greenland Biotech Co.,Ltd. Add: Mohekou Industrial Zone, Bengbu, Anhui, China. Tel:0552-5875300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06943566100378 EUDAMEDFDA UDI
- Basic UDI-DI
- 69435661Denture003S2 EUDAMED
- FDA Product Code
- KOQ FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Karaya denture adhesive FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3410 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Y-Kelin® by Anhui Greenland Biotech Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69435661Denture003S2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Anhui Greenland Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000026195
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 90f6c94f-c60e-47ff-a653-97bc24b66eea 61 fields · synced Jun 1, 2026
- FDA UDI c02c350b-371c-4b73-bfc4-5834d26af9d3 33 fields · synced May 30, 2026