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Hvese

EUDAMEDFDA UDI

Class I (EU MDR)

Ref HVESE

by DCI International, LLC

Identity

Trade Name
DCI FDA UDI
Generic Name
Dental suction system cannula, reusable FDA UDI
Device Name
HVESE EUDAMED
Autoclavable Short Vacuum Valve w/Quick Disconnect, to fit A-dec® FDA UDI
Model / Reference
HVESE EUDAMED
5060 FDA UDI
Description
Autoclavable Short Vacuum Valve w/Quick Disconnect, to fit A-dec® FDA UDI

Identifiers

Catalog Number
5060 FDA UDI
Primary DI / UDI-DI
00810021431147 EUDAMEDFDA UDI
Basic UDI-DI
081002143HVESEUW EUDAMED
Direct Marketing DI
00810021431147 EUDAMED
FDA Product Code
EHZ FDA UDI
EMDN Code
Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
GMDN Term
Dental suction system cannula, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.6640 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Hvese by DCI International, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
US-MF-000022306
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED cf68c04b-20d3-4d1c-a7b8-536ae0dc3517 61 fields · synced Jun 18, 2026
  • FDA UDI 2aae1c74-fb79-4b46-bc11-90db8d572dff 35 fields · synced May 30, 2026