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ReSolve®, StayFIX®,

by Merit Medical Systems, Inc.

Ref RLCMB-NV-10-SFX/AModel ReSolve®

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450014523 Basic UDI-DI 00884450014523UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450014523 UDI-DI Date16 Jul 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Closed-wound drain, non-bioabsorbable
Device Name
ReSolve Locking
Model / Ref / Catalog
ReSolve® EUDAMED
RLCMB-NV-10-SFX/A EUDAMED
A GUDID
RLCMB-NV-10-SFX GUDID
Primary DI / UDI-DI
00884450014523
Basic UDI-DI
B-00884450014523
FDA Product Code
GBX
EMDN Code
A060201 External drainage catheters and kits (abscesses, gallstones, cysts)
GMDN Term
Closed-wound drain, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
878.4200
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ReSolve®
RLCMB-NV-10-SFX/A
GUDID
A
Device ClassEUDAMED
Class IIb
GUDID
Class I
SterileEUDAMED
Yes
GUDID
No
ImplantableEUDAMED
Yes
GUDID
No

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Animal Tissues
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (13)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No