Identity
- Trade Name
- HI-CUT EUDAMED
- Device Name
- CARBON STEEL SURGICAL BLADE EUDAMED
- Model / Reference
- Surgical Blade No. 23 EUDAMED20123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902283201230 EUDAMED
- Basic UDI-DI
- B-08902283201230 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
- Portugal EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Manual scalpel blade, single-use
Hi-Cut by Kehr Surgical Private Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual scalpel blade, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
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- 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08902283201230 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kehr Surgical Private Limited
- EUDAMED SRN
- IN-MF-000021433
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 6650876b-4319-4e70-838a-3cda98d77c64 61 fields · synced Jul 26, 2026