Unbranded 110NS
by Advance Medical Designs, Inc.
Ref 110NS
Unbranded 110NS is a device classified as Class I in the EU and Class II in the US made by Advance Medical Designs, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 84834000110NS4Q) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00848340005237), active as of 7 Nov 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 | Number84834000110NS4Q 00848340005237 | Date2 Nov 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00848340005237 | Date19 Sep 2016 | StatusListed |
Official records
- EUDAMED public site 84834000110NS4Q
- AccessGUDID record 00848340005237
Across registries
- EUDAMED Basic UDI-DI 84834000110NS4Q registered 2 Nov 2026 Active
- FDA GUDID UDI-DI 00848340005237 listed 19 Sep 2016 Listed
Timeline
- Listed FDA GUDID 00848340005237
- Registered EUDAMED 84834000110NS4Q
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Unbranded
- Generic name
- Fluid transfer set, general-purpose
- Model / reference
- 110NS
- Primary DI / UDI-DI
- 00848340005237
- Basic UDI-DI
- 84834000110NS4Q
- FDA product code
- KPE
- EMDN code
- A0699 Drainage and fluid collection devices - other
- GMDN term
- Fluid transfer set, general-purpose
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 880.5025
- EU registration type
- Standard device
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
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 00848340005237: 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.
Similar devices in this category
Other devices filed under DRAINAGE AND FLUID COLLECTION DEVICES - OTHER.
- preOx IPS-CATH 530.027 by preOx.RS GmbH
- Hollister 9880 by Hollister Incorporated
- Arthrex® ABS-1052 by Arthrex, Inc.
- Avance® Solo 880050 by Mölnlycke Health Care AB
- ACTIV.A.C.™ M8275058/5 M8275058/10 by KCI USA, INC.
- Solventum™ ActiV.A.C.™ M8275058/5 M8275058/10 by KCI USA, INC.
- Arthrex® ABS-1050 by Arthrex, Inc.
- Introducer Sheath/Needle ISN1915 by Argon Medical Devices, Inc.
- preOx Flo4-CATH 540.118 by preOx.RS GmbH
- Hollister 9823 by Hollister Incorporated