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SatinSheet
EUDAMEDClass I (EU MDR)
Ref IM4131SHModel Positioning HorizontalRef IM4261SRef IM4224SRef IM4110SRef IM4201SRef IM4209SRef IM4240SRef IM4126SRef IM4229SRef IM4221SRef IM4252SRef IM4218SRef IM4220SRef IM4265SRef IM4225SRef IM4214SRef IM4255SRef IM4263SRef IM4197SRef IM4246SRef IM4248SRef IM4178SRef IM4238SRef IM4207SRef IM4137SRef IM4258SRef IM4158SRef IM4200SRef IM4187SRef IM4157SRef IM4237SRef IM4228SRef IM4243SRef IM4250SRef IM4108SRef IM4140SHRef IM4233SRef IM4115SRef IM4259SRef IM4216SRef IM4239SRef IM4122SRef IM4242SRef IM4167SRef IM4264SRef IM4208SRef IM4212SRef IM4244SRef IM4249SRef IM4226SRef IM4236SRef IM4175SRef IM4227SRef IM4235SRef IM4215S
Identity
- Trade Name
- SatinSheet EUDAMED
- Device Name
- SatinSheet EUDAMED
- Model / Reference
- Positioning Horizontal EUDAMEDIM4131SH EUDAMEDIM4261S EUDAMEDIM4224S EUDAMEDIM4110S EUDAMEDIM4201S EUDAMEDIM4209S EUDAMEDIM4240S EUDAMEDIM4126S EUDAMEDIM4229S EUDAMEDIM4221S EUDAMEDIM4252S EUDAMEDIM4218S EUDAMEDIM4220S EUDAMEDIM4265S EUDAMEDIM4225S EUDAMEDIM4214S EUDAMEDIM4255S EUDAMEDIM4263S EUDAMEDIM4197S EUDAMEDIM4246S EUDAMEDIM4248S EUDAMEDIM4178S EUDAMEDIM4238S EUDAMEDIM4207S EUDAMEDIM4137S EUDAMEDIM4258S EUDAMEDIM4158S EUDAMEDIM4200S EUDAMEDIM4187S EUDAMEDIM4157S EUDAMEDIM4237S EUDAMEDIM4228S EUDAMEDIM4243S EUDAMEDIM4250S EUDAMEDIM4108S EUDAMEDIM4140SH EUDAMEDIM4233S EUDAMEDIM4115S EUDAMEDIM4259S EUDAMEDIM4216S EUDAMEDIM4239S EUDAMEDIM4122S EUDAMEDIM4242S EUDAMEDIM4167S EUDAMEDIM4264S EUDAMEDIM4208S EUDAMEDIM4212S EUDAMEDIM4244S EUDAMEDIM4249S EUDAMEDIM4226S EUDAMEDIM4236S EUDAMEDIM4175S EUDAMEDIM4227S EUDAMEDIM4235S EUDAMEDIM4215S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708012005284 EUDAMED05708012559060 EUDAMED05708012003051 EUDAMED05708012001958 EUDAMED05708012001361 EUDAMED05708012002818 EUDAMED05708012004706 EUDAMED05708012005253 EUDAMED05708012004652 EUDAMED05708012003020 EUDAMED05708012558858 EUDAMED05708012002993 EUDAMED05708012003013 EUDAMED05708012559107 EUDAMED05708012004522 EUDAMED05708012002948 EUDAMED05708012558889 EUDAMED05708012559084 EUDAMED05708012004560 EUDAMED05708012004768 EUDAMED05708012004782 EUDAMED05708012002160 EUDAMED05708012003853 EUDAMED05708012025763 EUDAMED05708012002870 EUDAMED05708012558919 EUDAMED05708012558568 EUDAMED05708012001354 EUDAMED05708012558575 EUDAMED05708012004478 EUDAMED05708012003846 EUDAMED05708012004645 EUDAMED05708012004737 EUDAMED05708012004928 EUDAMED05708012001101 EUDAMED05708012003082 EUDAMED05708012004690 EUDAMED05708012001149 EUDAMED05708012558940 EUDAMED05708012002962 EUDAMED05708012003860 EUDAMED05708012001941 EUDAMED05708012004720 EUDAMED05708012004607 EUDAMED05708012559091 EUDAMED05708012002801 EUDAMED05708012002917 EUDAMED05708012004744 EUDAMED05708012004874 EUDAMED05708012004621 EUDAMED05708012003839 EUDAMED05708012002139 EUDAMED05708012004638 EUDAMED05708012003822 EUDAMED05708012002955 EUDAMED
- Basic UDI-DI
- 57080121001LJ EUDAMED
- EMDN Code
- Y122799 NON-MOTORIZED VEHICLES AND MEANS OF TRANSPORT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
SatinSheet by Etac Immedia A/S — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57080121001LJ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (55)
- EUDAMED fd2d167a-3a76-4b60-9743-23ecc899aacc 61 fields · synced Sep 30, 2026
- EUDAMED 18d47de9-c040-4094-9f9e-af70155b2800 61 fields · synced May 11, 2026
- EUDAMED ad47998a-e029-4201-a5bb-296e9f3221c1 61 fields · synced May 16, 2026
- EUDAMED ae99a656-32c7-47a9-bc90-94885ae512cd 61 fields · synced May 16, 2026
- EUDAMED 6e5d3706-f64b-481d-a1c3-550e87f72c7c 61 fields · synced May 16, 2026
- EUDAMED a3486127-e0c5-4906-baf3-722ee5caa4d2 61 fields · synced May 16, 2026
- EUDAMED d2490a5a-ca17-4b70-b9e9-18a9da0f8f3e 61 fields · synced May 16, 2026
- EUDAMED ef3fe1a8-9976-4c88-ac21-aa746982fd98 61 fields · synced May 16, 2026
- EUDAMED 3316c015-56c4-4d95-a775-68c666a7d35c 61 fields · synced May 16, 2026
- EUDAMED 4d7620de-3d85-45fc-8873-a883b651a544 61 fields · synced May 16, 2026
- EUDAMED b88fe403-934b-4c98-b8f0-a37cd86de6a7 61 fields · synced May 16, 2026
- EUDAMED 2cccf6ca-4a7a-4da3-8daf-0fc030091be6 61 fields · synced May 17, 2026
- EUDAMED 26425dd9-43b4-465e-b3e5-963efc5b0767 61 fields · synced May 17, 2026
- EUDAMED de17dc04-07b0-4bf6-9cc8-2ebe97cf097b 61 fields · synced May 17, 2026
- EUDAMED ca03a32c-8ca6-487f-b8c4-22479b691fa1 61 fields · synced May 17, 2026
- EUDAMED a4c790e6-2a51-446a-bbae-d1c8a5a2f6d5 61 fields · synced May 17, 2026
- EUDAMED f9bd243a-52b0-4cbc-a580-c4dc086a4b8d 61 fields · synced May 17, 2026
- EUDAMED d5c8a211-8fc5-41f1-afb2-3d586052ae27 61 fields · synced May 17, 2026
- EUDAMED 05ddddc5-6bd1-499f-9480-7cffb37db331 61 fields · synced May 17, 2026
- EUDAMED 5ec38b76-d91b-4641-a8e4-ec4c6210fb56 61 fields · synced May 17, 2026
- EUDAMED ec67f58e-e49b-4f80-b121-0473dbfd1a0f 61 fields · synced May 17, 2026
- EUDAMED 23c06579-f5c9-4266-9752-967e26343da7 61 fields · synced May 17, 2026
- EUDAMED 983d4b50-050a-4956-b0b4-2d687b16f965 61 fields · synced May 17, 2026
- EUDAMED fad95caf-e441-43b0-9866-acbc539238ac 61 fields · synced May 17, 2026
- EUDAMED b220d0fe-f44b-4397-815c-f6caa4b81c06 61 fields · synced May 17, 2026
- EUDAMED 116dbb21-7098-4852-950e-0d9a105d294a 61 fields · synced May 17, 2026
- EUDAMED eb0111b0-1e23-4f37-b5a9-906ec5f27263 61 fields · synced May 17, 2026
- EUDAMED 455822ad-54d5-4703-8d08-ab7240349306 61 fields · synced May 18, 2026
- EUDAMED c99d754a-5091-4052-ad1b-4e11844de22a 61 fields · synced May 18, 2026
- EUDAMED d408e582-f8f7-4448-ab8d-afec7fb0566a 61 fields · synced May 18, 2026
- EUDAMED 67cb989b-2606-470a-9bd1-eb130f32ac02 61 fields · synced May 18, 2026
- EUDAMED 6e08d9c9-1e5f-47d3-b3b4-bb0723f1bafc 61 fields · synced May 18, 2026
- EUDAMED 81517b1e-baeb-4433-876f-bfe039f5581c 61 fields · synced May 18, 2026
- EUDAMED 1660f7c0-0fa3-48e1-a102-34a5e15f47e2 61 fields · synced May 18, 2026
- EUDAMED 46715087-414d-487f-97af-0a57580885ee 61 fields · synced May 18, 2026
- EUDAMED cadefd5b-3345-4a91-b3ee-477122b6c011 61 fields · synced May 18, 2026
- EUDAMED 4146798d-33d7-481b-8700-e51a53227845 61 fields · synced May 18, 2026
- EUDAMED 06967588-6e02-42cf-938f-757f9514b708 61 fields · synced May 18, 2026
- EUDAMED 8dddd85b-bf08-4dd8-a17e-e8a842f4e594 61 fields · synced May 18, 2026
- EUDAMED 6947c94a-6c17-4c70-b709-85d88c77ca1f 61 fields · synced May 18, 2026
- EUDAMED edc21bd0-22fe-414c-87df-4abd3b109550 61 fields · synced May 18, 2026
- EUDAMED 4e79d47b-f56c-441d-be54-3ac8875f69a7 61 fields · synced May 18, 2026
- EUDAMED 28feb2da-f010-49b1-8ad5-b3ea077b193d 61 fields · synced May 18, 2026
- EUDAMED 76ae019d-a809-4471-9c50-bbe04e977ed4 61 fields · synced May 18, 2026
- EUDAMED da1d82e9-8fe0-41f6-9f18-712871fd7fcc 61 fields · synced May 18, 2026
- EUDAMED ff8212b8-e1d4-460e-b0cc-426a3a645fbf 61 fields · synced May 18, 2026
- EUDAMED 92e6fbc6-8ff3-4f44-80b2-f471b382dc2a 61 fields · synced May 18, 2026
- EUDAMED 46d1cf55-acb3-4648-9e4f-7a836a3b0e47 61 fields · synced May 18, 2026
- EUDAMED 0149c2e8-1820-41f0-987c-40efdc07ab30 61 fields · synced May 19, 2026
- EUDAMED 112e3e6e-0e1f-4c0d-a895-1b4b9932535c 61 fields · synced May 19, 2026
- EUDAMED 2b7cdae1-c85d-4702-acd9-941b276d6885 61 fields · synced May 19, 2026
- EUDAMED 52b0237c-189d-4beb-a057-8d8dd4cb2557 61 fields · synced May 19, 2026
- EUDAMED ec62732f-2a44-4afe-9a1f-fba1c9f1270a 61 fields · synced May 19, 2026
- EUDAMED 89c6bb57-41fa-4fd4-aba1-d5d81ba5b032 61 fields · synced May 19, 2026
- EUDAMED 4ebc8385-c8da-4be3-bc71-9c2a2184cc63 61 fields · synced May 19, 2026