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Absorbable Surgical Suture With / Without Needle - PGLA Suture
EUDAMEDClass III (EU MDR)
Ref G6500Model Without Needle
Identity
- Device Name
- Absorbable Surgical Suture With / Without Needle - PGLA Suture EUDAMED
- Model / Reference
- Without Needle EUDAMEDG6500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938535553958 EUDAMED
- Basic UDI-DI
- B-06938535553958 EUDAMED
- EMDN Code
- H010101020203 POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITHOUT NEEDLE EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
Absorbable Surgical Suture With / Without Needle - PGLA Suture by Huaiyin Medical Instruments Co., Ltd. — Class III — MDD — listed in EUDAMED
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-06938535553958 | Class III | Active |
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Manufacturer
- Manufacturer
- Huaiyin Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000003351
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED e8cdf355-7a25-42f9-8ce2-8e39662ad5b5 61 fields · synced Jul 23, 2026