Oils
by CooperSurgical, Inc. 5 variants
Ref LGOL-100
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00888937028638 | Date11 May 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number0888937TD041ZH 00888937028638 | Date17 Oct 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Oils EUDAMEDLifeGlobal® Media GUDID
- Generic Name
- IVF medium
- Device Name
- Liquid Paraffin
- Model / Ref / Catalog
- LGOL-100 EUDAMEDLGOL-100M GUDID
- Primary DI / UDI-DI
- 00888937028638
- Basic UDI-DI
- 0888937TD041ZH
- Direct Marketing DI
- 00888937028638
- 510(k) Number
- FDA Product Code
- MQL
- EMDN Code
- U08020503 Materials/culture media for assisted reproduction
- GMDN Term
- IVF medium
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 884.6180
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | LGOL-100 | LGOL-100M |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000002607
- Authorised representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Other devices from CooperSurgical, Inc.
Properties
Other properties (20)
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No