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Alpha Mega

EUDAMED

Class I (EU MDR)

Ref syringe typeModel syringe type, needle tube typeRef HG-NI01Model HG-NI01,HG-NI02,HG-NI03,HG-NI04,HG-NI05,HG-NI06,HG-NI07,HG-NI08,HG-NI09,HG-NI10,HG-NI11, HG-NI12, HG-NI13

by Hangzhou Weize Imp & Exp Co., Ltd.

Identity

Trade Name
ALPHA MEGA EUDAMED
Device Name
Nasal Irrigator EUDAMED
Nasal Irrigator / Nasal washer / Nasal syringe / Nasal aspirator / Nasal cleaner EUDAMED
Model / Reference
syringe type, needle tube type EUDAMED
syringe type EUDAMED
HG-NI01,HG-NI02,HG-NI03,HG-NI04,HG-NI05,HG-NI06,HG-NI07,HG-NI08,HG-NI09,HG-NI10,HG-NI11, HG-NI12, HG-NI13 EUDAMED
HG-NI01 EUDAMED

Identifiers

Primary DI / UDI-DI
03770019423196 EUDAMED
Basic UDI-DI
697654367NI202307SD EUDAMED
EMDN Code
Q030199 NASOPHARYNGEAL DEVICES - OTHER EUDAMED
Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Belgium EUDAMED
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMED

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

Alpha Mega by Hangzhou Weize Imp & Exp Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Hangzhou Weize Imp & Exp Co., Ltd.
EUDAMED SRN
CN-MF-000036544
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED 58cc0e09-cd0f-4f2d-bf61-de64762599d3 61 fields · synced Jun 19, 2026
  • EUDAMED 4b6b4bc0-7d13-4951-940b-4b278006d5cd 61 fields · synced Jun 19, 2026