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Mani Sutures Polypropylene - 10-0 Polypropylene
EUDAMEDClass IIb (EU MDR)
Ref 1415Ref 2451LRef 1460PRef 1417SRef 1455PRef 1470Ref 1417
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES POLYPROPYLENE - 10-0 POLYPROPYLENE EUDAMED
- Device Name
- MANI SUTURES POLYPROPYLENE EUDAMED
- Model / Reference
- 1415 EUDAMED2451L EUDAMED1460P EUDAMED1417S EUDAMED1455P EUDAMED1470 EUDAMED1417 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951401399 EUDAMED04546951402372 EUDAMED04546951401535 EUDAMED04546951401368 EUDAMED04546951401580 EUDAMED04546951401740 EUDAMED04546951401375 EUDAMED
- Basic UDI-DI
- B-04546951401399 EUDAMEDB-04546951402372 EUDAMEDB-04546951401535 EUDAMEDB-04546951401368 EUDAMEDB-04546951401580 EUDAMEDB-04546951401740 EUDAMEDB-04546951401375 EUDAMED
- EMDN Code
- H010201010401 POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Mani Sutures Polypropylene - 10-0 Polypropylene by Mani, Inc. — Class IIb — 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-04546951401399 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (7)
- EUDAMED 46bc8fde-6ba9-482c-8cff-b0ff1b25d0bd 61 fields · synced Aug 1, 2026
- EUDAMED b2b100ae-4055-4d99-b7ba-7032d0936bd3 61 fields · synced May 17, 2026
- EUDAMED a155c163-3607-4917-9e03-1dcb5f91336c 61 fields · synced May 17, 2026
- EUDAMED 6ac52611-bec2-4911-b347-29a0907b1fa1 61 fields · synced May 18, 2026
- EUDAMED 6ff902ae-2aa7-41ae-a980-28499e583e69 61 fields · synced May 18, 2026
- EUDAMED f4f2b5f6-45c7-4390-8679-ea64489502ab 61 fields · synced May 18, 2026
- EUDAMED 88e35d7d-1bb4-4579-b09b-4a1990ab1755 61 fields · synced May 19, 2026