Identity
- Trade Name
- PRIMEDGE EUDAMED
- Device Name
- SURGICAL BLADES WITH HANDLE EUDAMED
- Model / Reference
- 0910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951933822105 EUDAMED
- Basic UDI-DI
- 69519338DSGJ EUDAMED
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Primedge by Huaian Tianda Medical Instruments 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 | 69519338DSGJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Huaian Tianda Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000031504
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED ebeb53a4-a4c4-480d-8369-d42efe74e433 61 fields · synced Jun 18, 2026