Identity
- Trade Name
- Gauze Non-woven EUDAMEDBoston Scientific FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- Non Woven Sponge EUDAMED
- Model / Reference
- SMG-218-200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06921865500013 EUDAMEDFDA UDI
- Basic UDI-DI
- 69218655NJEKNWS01WY EUDAMED
- FDA Product Code
- NAB FDA UDI
- EMDN Code
- M0202010102 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4014 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gauze Non-woven by Jianerkang Medical 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 | 69218655NJEKNWS01WY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 b8fe45e5-3ab3-4a29-8290-bdb9864a816b 61 fields · synced Aug 3, 2026
- FDA UDI c5c69bfd-8338-4c3f-a9e7-3a5fddefce41 32 fields · synced May 30, 2026