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Paramount
EUDAMEDClass IIa (EU MDR)
Ref PSM62SModel 61, 61S, 62, 62S, 63, 64, 65, 65A, 67, 68, 69, 90, 91
Identity
- Trade Name
- Paramount EUDAMED
- Device Name
- Chisel/Fine range Blade EUDAMED
- Model / Reference
- 61, 61S, 62, 62S, 63, 64, 65, 65A, 67, 68, 69, 90, 91 EUDAMEDPSM62S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903175089097 EUDAMED
- Basic UDI-DI
- 8903175PSLCHB6B 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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Also classified as Manual scalpel blade, single-use.
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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 | 8903175PSLCHB6B | 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 f43f3769-4521-4fb5-8a24-ee7de671c2df 61 fields · synced Jun 18, 2026