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Countourel
EUDAMEDClass III (EU MDR)
Ref DDH-18G-SY2570WHRef DDH-18G-S2570WHRef JM2650Ref JM2940Ref DDH-19G-S2570WHRef JM3025Ref JMJB-T 21175Model MS2160L70Ref DDH-18G-SE2570LHRef DDH-18G-S2570LHRef JM3038LRef DDH-18G-SY2570LHRef DDH-18G-SE2570WHRef JMJB-I 27205Model JMNO-27G-5090URef JM3038
Identity
- Trade Name
- Countourel EUDAMED
- Device Name
- Sterile Single Use Absorbable Polydioxanone Suture with Needle EUDAMED
- Model / Reference
- DDH-18G-SY2570WH EUDAMEDDDH-18G-S2570WH EUDAMEDJM2650 EUDAMEDJM2940 EUDAMEDDDH-19G-S2570WH EUDAMEDJM3025 EUDAMEDMS2160L70 EUDAMEDJMJB-T 21175 EUDAMEDDDH-18G-SE2570LH EUDAMEDDDH-18G-S2570LH EUDAMEDJM3038L EUDAMEDDDH-18G-SY2570LH EUDAMEDDDH-18G-SE2570WH EUDAMEDJMNO-27G-5090U EUDAMEDJMJB-I 27205 EUDAMEDJM3038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800047817546 EUDAMED08800047817485 EUDAMED08800047830668 EUDAMED08800047830590 EUDAMED08800047817508 EUDAMED08800047830606 EUDAMED08800047830613 EUDAMED08800047817515 EUDAMED08800047817478 EUDAMED08800047830675 EUDAMED08800047817539 EUDAMED08800047817522 EUDAMED08800047830637 EUDAMED08800047830682 EUDAMED
- Basic UDI-DI
- B-08800047817546 EUDAMEDB-08800047817485 EUDAMEDB-08800047830668 EUDAMEDB-08800047830590 EUDAMEDB-08800047817508 EUDAMEDB-08800047830606 EUDAMEDB-08800047830613 EUDAMEDB-08800047817515 EUDAMEDB-08800047817478 EUDAMEDB-08800047830675 EUDAMEDB-08800047817539 EUDAMEDB-08800047817522 EUDAMEDB-08800047830637 EUDAMEDB-08800047830682 EUDAMED
- EMDN Code
- H010101010104 MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria 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
Countourel by J world 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-08800047817546 | Class III | Active |
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Manufacturer
- Manufacturer
- J world Co., Ltd.
- EUDAMED SRN
- KR-MF-000026588
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (14)
- EUDAMED 954caea1-dfe0-4216-b6c4-ca2600999f5a 61 fields · synced Sep 30, 2026
- EUDAMED c7f5fed2-6d11-41ee-a870-ece7284fd8a3 61 fields · synced May 16, 2026
- EUDAMED 09256c7d-1d66-40e4-9a79-2969389f3bfd 61 fields · synced May 16, 2026
- EUDAMED 2e802beb-41f7-49fb-b419-14e50fc70f69 61 fields · synced May 16, 2026
- EUDAMED a2fdabed-2c23-47b1-ace0-12d8555d23b5 61 fields · synced May 17, 2026
- EUDAMED f20c705e-d0a3-4233-938b-9cc9ddda7166 61 fields · synced May 17, 2026
- EUDAMED 4a4861f4-d02f-476c-a5b3-3d424677c4b3 61 fields · synced May 17, 2026
- EUDAMED 64945288-3c0e-4d64-a19f-1efc5b3d1568 61 fields · synced May 17, 2026
- EUDAMED 1754b60c-58e4-4062-8f98-2232f448eb3d 61 fields · synced May 18, 2026
- EUDAMED 6b64ee20-d22f-4205-87a2-7f74c4ab0290 61 fields · synced May 18, 2026
- EUDAMED f5d75025-064a-456a-906e-34201b7a467c 61 fields · synced May 18, 2026
- EUDAMED ebc34cf0-a293-4250-b08c-56b07f53c440 61 fields · synced May 18, 2026
- EUDAMED 7139b798-c074-48db-bcce-8142d2f7ae3c 61 fields · synced May 18, 2026
- EUDAMED b4b5e4ce-482c-48ff-b913-eb0c67bfac5e 61 fields · synced May 19, 2026