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Paramount
EUDAMEDClass IIa (EU MDR)
Ref PDSS36DModel 9, 10, 10A, 11, 11K, 12, 13, 14, 15, 15B, 15C, 15D, 15S, 16, 17, 18, 19, 20, 21, 22, 22A, 23, 24, 25, 26, 36, 11P, 12D, 24D, 34, 36D
Identity
- Trade Name
- Paramount EUDAMED
- Device Name
- Disposable scalpel with or without safety features EUDAMED
- Model / Reference
- 9, 10, 10A, 11, 11K, 12, 13, 14, 15, 15B, 15C, 15D, 15S, 16, 17, 18, 19, 20, 21, 22, 22A, 23, 24, 25, 26, 36, 11P, 12D, 24D, 34, 36D EUDAMEDPDSS36D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903175000382 EUDAMED
- Basic UDI-DI
- 8903175PSLDS75 EUDAMED
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE 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
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
Paramount by Paramount Surgimed Limited — 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
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- 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 | 8903175PSLDS75 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paramount Surgimed Limited
- EUDAMED SRN
- IN-MF-000021682
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED e9899a76-e7f3-4d4f-b8b9-999518c9718e 61 fields · synced Jun 18, 2026