Identity
- Trade Name
- HISPA EUDAMED
- Device Name
- Drainage Suction Equipment EUDAMED
- Model / Reference
- see Appendix I Model EUDAMEDF15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977849480628 EUDAMED
- Basic UDI-DI
- 697784948008TJ EUDAMED
- EMDN Code
- A060199 SURGICAL DRAINAGE SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Hispa by Guangdong Hispa Med 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697784948008TJ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Hispa Med Co., Ltd.
- EUDAMED SRN
- CN-MF-000045399
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 3cab6a9a-b8de-483d-8d48-c95f1c9b4dd7 61 fields · synced Jun 18, 2026