Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel ) FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- 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 EUDAMED11 EUDAMED11# FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938535543263 EUDAMEDFDA UDI
- Basic UDI-DI
- 69385355SurgicalbladeCRWE EUDAMED
- Direct Marketing DI
- 06938535543263 EUDAMED
- FDA Product Code
- GES FDA UDI
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Manual scalpel blade, single-use
Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel ) by Huaiyin Medical Instruments Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA…
Similar devices
Also classified as Manual scalpel blade, single-use.
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- Paramount — Paramount Surgimed Limited · Class IIa
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huaiyin Medical Instruments Co., Ltd.
Sources (2)
- FDA UDI 364b2542-4443-4c6f-ae20-e3772b0891fe 32 fields · synced Jul 15, 2026
- EUDAMED f74ce3b2-81a6-4bc7-aa6e-d9e6c01aaf81 61 fields · synced Jul 15, 2026