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Sterile Bacteriostatic Lubricating Gel
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SLT-395-50
Identity
- Trade Name
- Sterile Bacteriostatic Lubricating Gel EUDAMEDEndoGlide+™ FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- Lubricating Jelly EUDAMED
- Model / Reference
- SLT-395-50 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840253103055 EUDAMED26921865500055 FDA UDI
- Basic UDI-DI
- B-00840253103055 EUDAMED
- FDA Product Code
- KMJ FDA UDI
- EMDN Code
- V9007 STERILE INSTRUMENT LUBRICANTS EUDAMED
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 880.6375 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sterile Bacteriostatic Lubricating Gel by Jianerkang Medical Co., Ltd. — Class IIa — 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-00840253103055 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Jianerkang Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011206
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED a3c010e6-d5bc-4f8d-aa10-3aa3f5761a2d 61 fields · synced Jun 19, 2026
- FDA UDI ac64d7f4-bae5-4164-8652-49613ebf8143 33 fields · synced May 30, 2026