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IH2 SLA Fixture
EUDAMEDClass IIb (EU MDR)
Ref IH2FR6007SModel IH IMPLANT SYSTEM Ref BIH2FR4015SRef BIH2FR3513SRef IH2FR4015SRef BIH2FR3508SRef BIH2FR4010SRef BIH2FR6011SRef AIH2FR4007SRef IH2FM3510SRef BIH2FR4508SRef BIH2FR5007SRef AIH2FR4013SRef BIH2FR5011SRef BIH2FR3507SRef IH2FM3508SModel IH IMPLANT SYSTEMRef BIH2FR3510SRef IH2FR6008SRef IH2FR3510SRef BIH2FR4507SRef AIH2FR6010SRef BIH2FR5010SRef AIH2FR6013SRef BIH2FR5013SRef IH2FR5011SRef AIH2FR3511SRef BIH2FR4510SRef BIH2FR6013SRef BIH2FR4007SRef BIH2FR5015SRef BIH2FM3515SRef AIH2FR6007SRef BIH2FR4008SRef IH2FR4011SRef BIH2FR3511SRef IH2FM3513SRef IH2FR4513SRef BIH2FM3511SRef BIH2FM3510SRef BIH2FR5008SRef IH2FR3511SRef IH2FR5010SRef BIH2FR6010SRef AIH2FR3513SRef AIH2FR4513SRef AIH2FR5007SRef IH2FR4008S
Identity
- Trade Name
- IH2 SLA Fixture EUDAMED
- Device Name
- IH2 SLA Fixture EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDIH2FR6007S EUDAMEDBIH2FR4015S EUDAMEDBIH2FR3513S EUDAMEDIH2FR4015S EUDAMEDBIH2FR3508S EUDAMEDBIH2FR4010S EUDAMEDBIH2FR6011S EUDAMEDAIH2FR4007S EUDAMEDIH2FM3510S EUDAMEDBIH2FR4508S EUDAMEDBIH2FR5007S EUDAMEDAIH2FR4013S EUDAMEDBIH2FR5011S EUDAMEDBIH2FR3507S EUDAMEDIH2FM3508S EUDAMEDBIH2FR3510S EUDAMEDIH2FR6008S EUDAMEDIH2FR3510S EUDAMEDBIH2FR4507S EUDAMEDAIH2FR6010S EUDAMEDBIH2FR5010S EUDAMEDAIH2FR6013S EUDAMEDBIH2FR5013S EUDAMEDIH2FR5011S EUDAMEDAIH2FR3511S EUDAMEDBIH2FR4510S EUDAMEDBIH2FR6013S EUDAMEDBIH2FR4007S EUDAMEDBIH2FR5015S EUDAMEDBIH2FM3515S EUDAMEDAIH2FR6007S EUDAMEDBIH2FR4008S EUDAMEDIH2FR4011S EUDAMEDBIH2FR3511S EUDAMEDIH2FM3513S EUDAMEDIH2FR4513S EUDAMEDBIH2FM3511S EUDAMEDBIH2FM3510S EUDAMEDBIH2FR5008S EUDAMEDIH2FR3511S EUDAMEDIH2FR5010S EUDAMEDBIH2FR6010S EUDAMEDAIH2FR3513S EUDAMEDAIH2FR4513S EUDAMEDAIH2FR5007S EUDAMEDIH2FR4008S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041300303 EUDAMED08800041301638 EUDAMED08800041301560 EUDAMED08800041300174 EUDAMED08800041301539 EUDAMED08800041301607 EUDAMED08800041301799 EUDAMED08800041300853 EUDAMED08800041300020 EUDAMED08800041301652 EUDAMED08800041301706 EUDAMED08800041300891 EUDAMED08800041301737 EUDAMED08800041301522 EUDAMED08800041300013 EUDAMED08800041301546 EUDAMED08800041300310 EUDAMED08800041300082 EUDAMED08800041301645 EUDAMED08800041301058 EUDAMED08800041301720 EUDAMED08800041301072 EUDAMED08800041301744 EUDAMED08800041300273 EUDAMED08800041300822 EUDAMED08800041301669 EUDAMED08800041301805 EUDAMED08800041301584 EUDAMED08800041301751 EUDAMED08800041301515 EUDAMED08800041301034 EUDAMED08800041301591 EUDAMED08800041300150 EUDAMED08800041301553 EUDAMED08800041300044 EUDAMED08800041300228 EUDAMED08800041301492 EUDAMED08800041301485 EUDAMED08800041301713 EUDAMED08800041300099 EUDAMED08800041300266 EUDAMED08800041301782 EUDAMED08800041300839 EUDAMED08800041300952 EUDAMED08800041300976 EUDAMED08800041300136 EUDAMED
- Basic UDI-DI
- B-08800041300303 EUDAMEDB-08800041301638 EUDAMEDB-08800041301560 EUDAMEDB-08800041300174 EUDAMEDB-08800041301539 EUDAMEDB-08800041301607 EUDAMEDB-08800041301799 EUDAMEDB-08800041300853 EUDAMEDB-08800041300020 EUDAMEDB-08800041301652 EUDAMEDB-08800041301706 EUDAMEDB-08800041300891 EUDAMEDB-08800041301737 EUDAMEDB-08800041301522 EUDAMEDB-08800041300013 EUDAMEDB-08800041301546 EUDAMEDB-08800041300310 EUDAMEDB-08800041300082 EUDAMEDB-08800041301645 EUDAMEDB-08800041301058 EUDAMEDB-08800041301720 EUDAMEDB-08800041301072 EUDAMEDB-08800041301744 EUDAMEDB-08800041300273 EUDAMEDB-08800041300822 EUDAMEDB-08800041301669 EUDAMEDB-08800041301805 EUDAMEDB-08800041301584 EUDAMEDB-08800041301751 EUDAMEDB-08800041301515 EUDAMEDB-08800041301034 EUDAMEDB-08800041301591 EUDAMEDB-08800041300150 EUDAMEDB-08800041301553 EUDAMEDB-08800041300044 EUDAMEDB-08800041300228 EUDAMEDB-08800041301492 EUDAMEDB-08800041301485 EUDAMEDB-08800041301713 EUDAMEDB-08800041300099 EUDAMEDB-08800041300266 EUDAMEDB-08800041301782 EUDAMEDB-08800041300839 EUDAMEDB-08800041300952 EUDAMEDB-08800041300976 EUDAMEDB-08800041300136 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb 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
IH2 SLA Fixture by SEWONMEDIX 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-08800041300303 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (46)
- EUDAMED 0152767c-b3ca-4e46-8473-ec95a451180c 61 fields · synced Sep 18, 2026
- EUDAMED 2fb63699-9357-44d8-8b21-9203688d9525 61 fields · synced May 16, 2026
- EUDAMED 52003740-dc84-40f4-a952-27f61f66afaa 61 fields · synced May 16, 2026
- EUDAMED b339c597-0c91-4487-a107-2122e0f4f5e4 61 fields · synced May 16, 2026
- EUDAMED e6675744-0207-46e2-84f7-cf5482ff0ec8 61 fields · synced May 16, 2026
- EUDAMED 430224ff-6869-4c0a-8e6f-a6a2eb89092d 61 fields · synced May 16, 2026
- EUDAMED 1e3576f9-dea6-4dac-9eb8-9a7c817ab6af 61 fields · synced May 16, 2026
- EUDAMED 9d42ce51-f7d6-4182-8524-ec77b5cf41c1 61 fields · synced May 16, 2026
- EUDAMED a2d0af86-de7d-4bf1-a03b-15093b0e5df7 61 fields · synced May 16, 2026
- EUDAMED 54f04822-2fa9-4898-8111-21c75a872671 61 fields · synced May 17, 2026
- EUDAMED b3c19dcb-a426-49ea-aaae-7e4f3475cb98 61 fields · synced May 17, 2026
- EUDAMED 98b503c3-e422-405f-92c2-b61ba2002332 61 fields · synced May 17, 2026
- EUDAMED 642dba40-ff34-4a7c-a1d1-1f5592979c39 61 fields · synced May 17, 2026
- EUDAMED a3d9203a-1c67-4c25-87b2-05479350d026 61 fields · synced May 17, 2026
- EUDAMED df648fd7-51b7-428f-91f3-a8a015fa272c 61 fields · synced May 17, 2026
- EUDAMED 6ce3a1ba-9d11-44f6-ad8a-755bcc64f757 61 fields · synced May 17, 2026
- EUDAMED 8a1d2ec0-7fd8-4268-8b46-f2d83aa8b2b5 61 fields · synced May 17, 2026
- EUDAMED 674ff38e-773a-4f69-9f2c-262c5b3db29e 61 fields · synced May 17, 2026
- EUDAMED 85b2ff96-0004-4d35-9185-940443b2e92c 61 fields · synced May 17, 2026
- EUDAMED 31496dba-46bf-4302-a4ab-33978f5e8cd5 61 fields · synced May 17, 2026
- EUDAMED 3baa6e99-b2a8-4c29-b608-be06305597e4 61 fields · synced May 17, 2026
- EUDAMED 53edabd7-1d49-43c7-b1ee-1478cd9be12d 61 fields · synced May 17, 2026
- EUDAMED a6b29814-cf72-494f-88b9-68c4a42f2407 61 fields · synced May 17, 2026
- EUDAMED f825dc52-554f-4683-b6a1-123aeca673eb 61 fields · synced May 18, 2026
- EUDAMED 31f07692-43a2-4de3-88f1-f725743c5dd9 61 fields · synced May 18, 2026
- EUDAMED f9475171-3197-4338-bd65-16b26703f43d 61 fields · synced May 18, 2026
- EUDAMED 59fd081c-981c-4109-b6f8-97169e484cae 61 fields · synced May 18, 2026
- EUDAMED df5ba6a1-77f9-4eb5-8efb-2942f01d9755 61 fields · synced May 18, 2026
- EUDAMED 0d944b5b-0fa9-4dbd-9487-d8788d105736 61 fields · synced May 18, 2026
- EUDAMED 314fe7ff-0952-47c6-9dcb-93114cff5834 61 fields · synced May 18, 2026
- EUDAMED b1b4310e-f20d-417e-b456-cedd0d1a1e98 61 fields · synced May 18, 2026
- EUDAMED 1371f3b3-cf23-4938-9f87-c1f40042558d 61 fields · synced May 18, 2026
- EUDAMED 4b913176-d91a-495f-9ad8-eecb5b9b082f 61 fields · synced May 18, 2026
- EUDAMED b3c65cf2-a376-4c71-824d-3bc101f6cc2a 61 fields · synced May 18, 2026
- EUDAMED e028f2c7-8d62-4404-8ace-0b9e69242adc 61 fields · synced May 18, 2026
- EUDAMED a17e7ef8-697d-4623-a92f-0ee5a594eb7f 61 fields · synced May 18, 2026
- EUDAMED b907e2ed-da1b-41f2-ab20-336944499a4f 61 fields · synced May 18, 2026
- EUDAMED 4287e120-d001-4770-b8eb-d0ebf28c27e4 61 fields · synced May 18, 2026
- EUDAMED 192663f7-8e21-4f8a-87ce-f2a080e03986 61 fields · synced May 18, 2026
- EUDAMED 445b0b15-fec9-4017-9559-bfb2d0038c5a 61 fields · synced May 18, 2026
- EUDAMED ffb2c159-f8a1-46ff-95d5-656072c87f23 61 fields · synced May 19, 2026
- EUDAMED cb7c9f13-4cb1-4968-8ecc-d4015e8ae5f3 61 fields · synced May 19, 2026
- EUDAMED 826c1454-1afc-4fc6-8a47-872bb2423a35 61 fields · synced May 19, 2026
- EUDAMED 2ba9c2b9-a1e7-480a-9e46-886a731e609f 61 fields · synced May 19, 2026
- EUDAMED b765e9e8-b0cc-4bfd-824f-defd148986be 61 fields · synced May 19, 2026
- EUDAMED 41952840-6773-4082-b1fc-9078b439f917 61 fields · synced May 19, 2026