← Back to catalogue
Nextech
EUDAMEDClass IIa (EU MDR)
Ref PCS15 (Primary)Model Carbon Steel Surgical Blades - 15 (size)
Identity
- Trade Name
- Nextech EUDAMED
- Device Name
- Carbon Steel Surgical Blades EUDAMED
- Model / Reference
- Carbon Steel Surgical Blades - 15 (size) EUDAMEDPCS15 (Primary) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903175091519 EUDAMED
- Basic UDI-DI
- B-08903175091519 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
- France 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
Nextech by Paramount Surgimed Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual scalpel blade, single-use.
- 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
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
- SURGISTAR — Surgistar Inc. · Class I
- Olympus — Olympus Winter & Ibe GmbH · Class II
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-08903175091519 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paramount Surgimed Limited
- EUDAMED SRN
- IN-MF-000021682
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED ae407e2e-c5a9-43b6-a1f3-107ebbe3ff73 61 fields · synced Jun 20, 2026