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Gynecological Obstetric Table
EUDAMEDFDA UDIClass I (EU MDR)
Ref -Model CreLife 100
Identity
- Trade Name
- LEWIN FDA UDI
- Generic Name
- Gynaecological operating table, electromechanical FDA UDI
- Device Name
- Gynecological Obstetric Table EUDAMED
- Model / Reference
- CreLife 100 EUDAMEDFDA UDI- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976041613018 EUDAMEDFDA UDI
- Basic UDI-DI
- 69760416173W3 EUDAMED
- FDA Product Code
- JEA FDA UDI
- EMDN Code
- Z12011201 OPERATING CHAIRS EUDAMED
- GMDN Term
- Gynaecological operating table, electromechanical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Gynecological Obstetric Table by Shandong Lewin Medical Equipment Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69760416173W3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shandong Lewin Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000038886
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 9f483002-cb48-43be-a32c-221a020b7a0c 61 fields · synced Jul 24, 2026
- FDA UDI ccf4c3d9-7f9b-4b08-a38f-5081e562e2cc 32 fields · synced May 27, 2026