← Back to catalogue
Mani Sutures Polypropylene - 10-0 Polypropylene
EUDAMEDClass IIb (EU MDR)
Ref 2021
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES POLYPROPYLENE - 10-0 POLYPROPYLENE EUDAMED
- Device Name
- MANI SUTURES POLYPROPYLENE EUDAMED
- Model / Reference
- 2021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951401962 EUDAMED
- Basic UDI-DI
- B-04546951401962 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-04546951401962 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 6f0fd38c-2975-4dc0-b789-c1622e8d48c9 61 fields · synced Jun 19, 2026