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Sterile Disposable Surgical Blade with/without Plastic Handle (Carbon Steel)
EUDAMEDClass IIa (EU MDR)
Ref 15CModel Sterile Disposable Surgical Blade with Plastic Handle、Sterile Disposable Surgical Blade
Identity
- Device Name
- Sterile Disposable Surgical Blade with/without Plastic Handle (Carbon Steel) EUDAMED
- Model / Reference
- Sterile Disposable Surgical Blade with Plastic Handle、Sterile Disposable Surgical Blade EUDAMED15C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938535543348 EUDAMED
- Basic UDI-DI
- 69385355SurgicalbladeCRWE EUDAMED
- Direct Marketing DI
- 06938535543348 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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: Manual scalpel blade, single-use
Sterile Disposable Surgical Blade with/without Plastic Handle (Carbon Steel) by Huaiyin Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED
Similar devices
Also classified as Manual scalpel blade, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
- Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
- Sterile Stainless Blades — Southmedic Incorporated · Class I
- Paramount — Paramount Surgimed Limited · Class IIa
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · 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 | 69385355SurgicalbladeCRWE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Huaiyin Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000003351
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 93b5b1a6-ac19-4ee7-95a5-1bffabbe3c04 61 fields · synced Jun 19, 2026