← Back to catalogue
Primedge
EUDAMEDClass IIa (EU MDR)
Ref 0712Model 9、10、10A、11、12、12B、12D、13、14、15、15A、15C、15D、16、18、19、20、21、22、22A、 23、24、25、25A、26、27、34、36
Identity
- Trade Name
- PRIMEDGE EUDAMED
- Device Name
- Surgical Blades EUDAMED
- Model / Reference
- 9、10、10A、11、12、12B、12D、13、14、15、15A、15C、15D、16、18、19、20、21、22、22A、 23、24、25、25A、26、27、34、36 EUDAMED0712 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951933811123 EUDAMED
- Basic UDI-DI
- 69519338SBGV EUDAMED
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Latvia 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
Category: Scalpel, single-use
Primedge by Huaian Tianda Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel, single-use.
- MANI ENT Knife — MANI, INC. · Class I
- Unique Edge — Unique Technologies, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Stylus — Surgical Specialties México, S. de R.L. de C.V. · Class I
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 | 69519338SBGV | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huaian Tianda Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000031504
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 6764fee4-6f1d-4820-a429-7c6e40684edb 61 fields · synced Jun 18, 2026