Sensicare PI
by Medline Industries, LP United States EUDAMEDGUDID
Ref MSG9060
Product code KGOEMDN T01010203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0888277DC41ESTNE | Date27 Feb 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10888277347878 | Date25 Nov 2025 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Sensicare PI EUDAMEDMedline GUDID
- Generic Name
- Polyisoprene surgical glove, non-powdered, non-antimicrobial
- Model / Ref / Catalog
- MSG9060
- Primary DI / UDI-DI
- 10888277347878
- Basic UDI-DI
- 0888277DC41ESTNE
- FDA Product Code
- KGO
- EMDN Code
- T01010203 Polyisopren surgical gloves
- GMDN Term
- Polyisoprene surgical glove, non-powdered, non-antimicrobial
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 878.4460
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000009717
- Authorised representative
- Medline International France FR-AR-000001814
Other devices from Medline Industries, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- 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
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 448fe360-ed0c-4f4a-a372-ec1d7f89c503
- FDA UDI 8a7e3ae7-dbb7-44c2-92a4-73b0eb914ffa