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Pgla
EUDAMEDClass III (EU MDR)
Ref YY1116-2020Model 6-0 75cm reverse cutting 3/8 13mm
Identity
- Trade Name
- PGLA EUDAMED
- Device Name
- PGLA EUDAMED
- Model / Reference
- 6-0 75cm reverse cutting 3/8 13mm EUDAMEDYY1116-2020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971642801864 EUDAMED
- Basic UDI-DI
- B-06971642801864 EUDAMED
- EMDN Code
- H0101010299 SYNTHETIC ABSORBABLE MULTIFILAMENT SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Pgla by Shandong Haidike Medical Products Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06971642801864 | Class III | Active |
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Manufacturer
- Manufacturer
- Shandong Haidike Medical Products Co Ltd
- EUDAMED SRN
- CN-MF-000026113
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 20d05f1f-00ea-4613-a4e8-631dd2ad989c 61 fields · synced Oct 6, 2026