SOL-M Blunt Fill Needle with Filter
by Sol-Millennium Medical, Inc. EUDAMEDGUDID
Active
Ref 110022F, 110023F, 110021FModel SOL-M Blunt Fill Needle with Filter
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00818392015942 | Date10 Mar 2025 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number081006243BLT3XW | Date27 Apr 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- SOL-M Blunt Fill Needle with Filter EUDAMEDSOL-M Blunt Fill Needle w/Filter 18G*1 1/2" GUDID
- Generic Name
- Medication transfer needle, filtering
- Model / Reference
- SOL-M Blunt Fill Needle with Filter, 110022F, 110023F, 110021F
- Primary DI / UDI-DI
- 00818392015942 EUDAMED00818392012408 EUDAMED00818392013917 EUDAMED00810062435791 GUDID
- Basic UDI-DI
- 081006243BLT3XW
- Direct Marketing DI
- 008183920159420081839201240800818392013917
- FDA Product Code
- GAA
- EMDN Code
- A010104 Needles for vial collection
- GMDN Term
- Medication transfer needle, filtering
- Device Class
- Class I
- Regulation Number
- 878.4800
- Market of Registration
- Poland
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 00818392015942 00818392012408 00818392013917 | 00810062435791 |
Manufacturer details
- EUDAMED SRN
- US-MF-000010890
- Authorised representative
- Sol-Millennium Europe Sp. z o.o. PL-AR-000010397
Other devices from Sol-Millennium Medical, Inc.
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No