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Paramount
EUDAMEDClass IIa (EU MDR)
Ref PCS19Model 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, 40, 40B, 60, 60B, 11P, 12D, 24D, 34, 36D, 1, 2, 3, 4, 5, 6, 8,10,12,15,1R, 2R, 3R, 1V, 2V, 3V
Identity
- Trade Name
- Paramount EUDAMED
- Device Name
- Surgical Blade 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, 40, 40B, 60, 60B, 11P, 12D, 24D, 34, 36D, 1, 2, 3, 4, 5, 6, 8,10,12,15,1R, 2R, 3R, 1V, 2V, 3V EUDAMEDPCS19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903175000351 EUDAMED
- Basic UDI-DI
- 8903175PSLSB7G 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
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
Paramount by Paramount Surgimed Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8903175PSLSB7G | 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 94331dcf-933d-4a6e-b92d-75c2914adabe 61 fields · synced Jun 19, 2026