← Back to catalogue
HugeMed
EUDAMEDClass IIa (EU MDR)
Ref HY-50AModel HY-45A, HY-45B, HY-50A, HY-50B
Identity
- Trade Name
- HugeMed EUDAMED
- Device Name
- Single-use Hysteroscope EUDAMED
- Model / Reference
- HY-45A, HY-45B, HY-50A, HY-50B EUDAMEDHY-50A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970462542759 EUDAMED
- Basic UDI-DI
- 69704625424017Z EUDAMED
- EMDN Code
- Z12020712 VIDEO HYSTEROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
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
HugeMed by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69704625424017Z | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b3ef7e1d-da72-4f95-8ff5-f6182def1511 61 fields · synced May 23, 2026