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Optimelle Strips СТРИПС ПЛАСТЫРИ МЕДИЦИНСКИЕ НА ТКАНЕВОЙ ОСНОВЕ
EUDAMEDClass I (EU MDR)
Ref FSCI154
by Pharmaplast
Identity
- Trade Name
- Optimelle Strips СТРИПС ПЛАСТЫРИ МЕДИЦИНСКИЕ НА ТКАНЕВОЙ ОСНОВЕ EUDAMED
- Device Name
- Skin closure strips EUDAMED
- Model / Reference
- FSCI154 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04603773791944 EUDAMED
- Basic UDI-DI
- 62220238PharmaStripQX EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Optimelle Strips СТРИПС ПЛАСТЫРИ МЕДИЦИНСКИЕ НА ТКАНЕВОЙ ОСНОВЕ by Pharmaplast — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 62220238PharmaStripQX | Class I | Active |
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Manufacturer
- Manufacturer
- Pharmaplast
- EUDAMED SRN
- EG-MF-000004501
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED dfbe47ae-9527-4814-bf76-0fa9cd312755 61 fields · synced Jun 11, 2026