LED Shadowless Operating Light
by Shandong Lewin Medical Equipment Co., Ltd. 12 variants
Model CreLed 3300
LED Shadowless Operating Light (CreLed 3300) is an operating room light (EU MDR Class I; FDA Class II; FDA product code FTD, Lamp, Surgical) made by Shandong Lewin Medical Equipment Co., Ltd., registered in EUDAMED on 14 Dec 2023 (Basic UDI-DI 69760416142VQ) and listed in FDA GUDID since 8 Feb 2023 (UDI-DI 06976041611069), active as of 22 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69760416142VQ 06976041611069 | Date14 Dec 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06976041611069 | Date8 Feb 2023 | StatusListed |
Official records
- EUDAMED public site 69760416142VQ
- AccessGUDID record 06976041611069
Across registries
- EUDAMED Basic UDI-DI 69760416142VQ registered 14 Dec 2023 Active
- FDA GUDID UDI-DI 06976041611069 listed 8 Feb 2023 Listed
Timeline
- Listed FDA GUDID 06976041611069
- Registered EUDAMED 69760416142VQ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Lewin
- Generic name
- Operating room light
- Device name
- LED Shadowless Operating Light
- Model / reference
- CreLed 3300
- Primary DI / UDI-DI
- 06976041611069
- Basic UDI-DI
- 69760416142VQ
- FDA product code
- FTD
- EMDN code
- Z12010701 Fixed scialytic lamps
- GMDN term
- Operating room light
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 878.4580
- EU registration type
- Standard device
- EU market of registration
- Poland
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
| Sterilise before use | No | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 06976041611069: EUDAMED states No, FDA GUDID states Yes.
Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
Manufacturer details
- EUDAMED SRN
- CN-MF-000038886
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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