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Exsudex XL Canister

by MediTop BV

Ref 16670-HZS, 16670-LL

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number871810489_CAN_NP Basic UDI-DI Date2 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08718104890121 UDI-DI Date7 Feb 2018ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Exsudex XL Canister EUDAMED
Exsudex disposable canister GUDID
Generic Name
Surgical suction system collection container, single-use
Model / Ref / Catalog
16670-HZS, 16670-LL, Large canister without tube, Large canister with luer-lock tube
Primary DI / UDI-DI
08718104890121, 08718104890114
Basic UDI-DI
871810489_CAN_NP
FDA Product Code
GCY
EMDN Code
A0680 Drainage and fluid collection devices - accessories
GMDN Term
Surgical suction system collection container, single-use
Device Class
Class I
Regulation Number
878.4680
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
16670-HZS
16670-LL
GUDID
Large canister without tube
Large canister with luer-lock tube

Manufacturer details

EUDAMED SRN
NL-MF-000010795

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date NoGUDIDYesGUDID
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Serial Number: No